With Advanced Clinical's Executive Vice President, Rosemarie Truman, attending the 2010 Mid-Atlantic Biotech Conference, we would like to provide you with our ideas on achieving breakthrough in biotechnology through R&D Productivity. The following abstract will be presented at the Conference today, and we are giving you an sneak peek online in case you can't make it to the conference!
With recent announcements of significant budget cuts in the R&D workforce and spending, it is clear the R&D model has changed for biotech companies and an innovative turnaround in R&D is needed. Advanced Clinical's poster presentation will demonstrate a codified framework for biotechnology companies to achieve true R&D productivity.
Through a strong framework and approach, biotech companies can ensure their product has market adoption and is differentiated; they can ensure operational efficiency in the clinical trial and they can make sure the medical/scientific focus is correct.
The comprehensive framework will assess the "what," the "how" and the "why" of R&D productivity.
1. What is needed for effective R&D productivity? First, the right medical / scientific focus is required. This includes, but is not limited to:
Protocol
Target label claims
Doses and routes
Enrollment and drop-out rates
Heterogeneity of the population
Precision endpoints
2. How can R&D productivity be achieved? Clinical trial operational execution factors to assess include, but are not limited to:
Clinical operations, enrollment, investigators and sites
Regulatory management
Data management
Biostatistics
Drug supply
Labs
Medical writing
Medical safety and monitoring
3. Why should the drug reach the market? Will it have adoption? Market viability and comparative effectiveness are critical to a drug's success.
By providing a framework for biotech companies to ensure their product is successful, they gain a higher probability of success in getting much needed products to market.
Friday, October 29, 2010
Wednesday, October 27, 2010
Advanced Clinical to Present an R&D Productivity Poster at the 2010 Mid-Atlantic Biotech Conference
Join our Facebook page and watch for an update and pictures following the conference! www.facebook.com/advclinical
Advanced Clinical, a leading provider of clinical research services, announced today that Executive Vice President Rosemarie Truman will present a poster on R&D productivity at the 2010 Mid-Atlantic Biotech Conference on Friday, October 29, 2010. Ms. Truman will provide an overview of Advanced Clinical’s R&D framework and approach, which biotech companies can use to ensure their product has market adoption, is differentiated, has operational efficiency in a clinical trial, and has the correct medical/scientific focus.
“We look forward to presenting our R&D productivity framework for the biotechnology sector,” said Rosemarie Truman. “The framework we will discuss is proven to create step-change R&D improvement by improving probability of success as well as reducing cycle time and costs.”
About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com.
Contact:
Rosemarie Truman
rtruman(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208
Advanced Clinical, a leading provider of clinical research services, announced today that Executive Vice President Rosemarie Truman will present a poster on R&D productivity at the 2010 Mid-Atlantic Biotech Conference on Friday, October 29, 2010. Ms. Truman will provide an overview of Advanced Clinical’s R&D framework and approach, which biotech companies can use to ensure their product has market adoption, is differentiated, has operational efficiency in a clinical trial, and has the correct medical/scientific focus.
“We look forward to presenting our R&D productivity framework for the biotechnology sector,” said Rosemarie Truman. “The framework we will discuss is proven to create step-change R&D improvement by improving probability of success as well as reducing cycle time and costs.”
About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com.
Contact:
Rosemarie Truman
rtruman(at)advancedclinical(dot)com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208
Friday, October 15, 2010
Working Her Dream Job: Insight from a Clinical Development Expert
Patricia Walicke MD, PhD, a core member of Advanced Clinical’s strategic advisory ecosystem, describes her experience in achieving her dream career: “I’ve followed a desire to try to make the world a better place and serve humanity through improving health and health care.”
As a strategic advisor, Dr. Walicke brings years of leadership strategy experience across several areas of clinical research, including protocol design and clinical plan development across multiple phases. Additionally, she has experience in regulatory submissions and interactions as well as medical monitoring and safety. Her expertise combined with her current work as an independent consultant for clinical development programs contributes to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies.
“The team at Advanced is very bright, dedicated and determined, and, by working together, we have the opportunity to share how to operate more efficiently and effectively in the industry,” said Patricia Walicke, Advanced Clinical Strategic Advisor.
Formerly a practicing neurologist, Dr. Walicke changed careers to drug development approximately 15 years ago. She has experience with biologics and small molecules, and has worked on indications in neurology, autoimmune rheumatologic disorders, dermatology, ophthalmology and oncology. She explains that creativity, balanced by practicality, is the key to drug development: “When evaluating a potential therapeutic, first it is important to think broadly of all the possible ways that it might be used in medicine. Then the range of indications needs to be narrowed down to what is feasible. Matching the mechanism of action of the compound to the pathophysiology of the disease is also an important determinant.”
Notably, Dr. Walicke led the Phase 3 team for approval of efalizumab (Raptiva) for psoriasis; helped design extension of rituximab to non-oncology indications, particularly multiple sclerosis; obtained the first clinical proof of concept for anti-NGF in analgesia; and has been awarded several drug patents. “Drug development was a way for me to help more people more efficiently. You can potentially help hundreds of thousands of people,” said Dr. Walicke.
In addition, Dr. Walicke took a leadership role in establishing clinical groups in two start-up companies and restructuring the clinical department for biopharmaceutical company Oxigene with relocation from the East Coast to the West Coast.
Of compiling clinical teams, Dr. Walicke says, “While it is important for the team to be knowledgeable, it is perhaps most important that the team members communicate effectively and stay focused on the overall goal.”
Dr. Walicke offers advice to others in the clinical field, based on attributes to which she credits her own success: “Represent the needs and interests of patients and clinicians within industry, follow the science, keep timelines and deliverables, and pay attention along the way.”
Find your dream job at www.advancedclinical.com
As a strategic advisor, Dr. Walicke brings years of leadership strategy experience across several areas of clinical research, including protocol design and clinical plan development across multiple phases. Additionally, she has experience in regulatory submissions and interactions as well as medical monitoring and safety. Her expertise combined with her current work as an independent consultant for clinical development programs contributes to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies.
“The team at Advanced is very bright, dedicated and determined, and, by working together, we have the opportunity to share how to operate more efficiently and effectively in the industry,” said Patricia Walicke, Advanced Clinical Strategic Advisor.
Formerly a practicing neurologist, Dr. Walicke changed careers to drug development approximately 15 years ago. She has experience with biologics and small molecules, and has worked on indications in neurology, autoimmune rheumatologic disorders, dermatology, ophthalmology and oncology. She explains that creativity, balanced by practicality, is the key to drug development: “When evaluating a potential therapeutic, first it is important to think broadly of all the possible ways that it might be used in medicine. Then the range of indications needs to be narrowed down to what is feasible. Matching the mechanism of action of the compound to the pathophysiology of the disease is also an important determinant.”
Notably, Dr. Walicke led the Phase 3 team for approval of efalizumab (Raptiva) for psoriasis; helped design extension of rituximab to non-oncology indications, particularly multiple sclerosis; obtained the first clinical proof of concept for anti-NGF in analgesia; and has been awarded several drug patents. “Drug development was a way for me to help more people more efficiently. You can potentially help hundreds of thousands of people,” said Dr. Walicke.
In addition, Dr. Walicke took a leadership role in establishing clinical groups in two start-up companies and restructuring the clinical department for biopharmaceutical company Oxigene with relocation from the East Coast to the West Coast.
Of compiling clinical teams, Dr. Walicke says, “While it is important for the team to be knowledgeable, it is perhaps most important that the team members communicate effectively and stay focused on the overall goal.”
Dr. Walicke offers advice to others in the clinical field, based on attributes to which she credits her own success: “Represent the needs and interests of patients and clinicians within industry, follow the science, keep timelines and deliverables, and pay attention along the way.”
Find your dream job at www.advancedclinical.com
Thursday, September 30, 2010
Advanced Clinical Announces Bernice Welles as a Core Member of its Strategic Advisory Ecosystem
Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem. 
Bannockburn, Ill. (Vocus) September 30, 2010
Advanced Clinical, a leading provider of clinical research services, announces Bernice Welles as a core member of its strategic advisory ecosystem.
As a strategic advisor, Bernice Welles has contributed to Advanced Clinical’s Industry Leading R&D Performance (ILRDP) framework that seeks to make the “business of R&D” more effective and efficient for Life Sciences companies. Bernice has been a key driver in the development and regulatory approval of drugs, biologics, devices as well as combination therapies across multiple therapeutic areas. “Moving a drug and/or biologic from development to approval is, possibly, the hardest earned process in the Life Sciences industry,” says Bernice Welles, Advanced Clinical Strategic Advisor.
Welles’ accomplishments span several leadership roles in companies at different stages of growth. At Genentech, Welles was appointed to several management positions to drive the drug and biologics development portfolio across multiple therapeutic areas. Two of Welles positions included: Senior Director of the Specialty Therapeutics Unit and Vice President of Product Development. One important program that Welles progressed was the Lucentis injection for wet age-related macular degeneration (AMD). AMD is a disease of the eye that is the leading cause of blindness in older Americans and causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities. By moving forward this program, several thousand patients were able to be treated.
Welles held a Venture Partner position at MPM Capital LLP, where she participated in discussions on medical devices and helped assess device instruments. At MPM, Welles also took the lead on several investments and helped portfolio companies such as CoTherix maneuver the regulatory process leading to an early approval for Ventavis®, a new therapy for pulmonary hypertension.
Welles currently holds executive positions as CEO of Alquest Therapeutics Inc. and Vice President, Clinical and Regulatory, of Enject Inc., both innovative biotechnology startup companies.
With years of experience heading teams across functional areas, Welles credits integration as being one of the keys to her success. Using her capability to integrate the knowledge she has gained during her career, Welles is able to pull together all of the elements of clinical and regulatory as well as leverage the science behind development programs to create a significant, positive impact on the Life Sciences industry.
“I am proud to be working with Advanced Clinical,” said Bernice Welles. “Being part of this expert strategic advisory team allows me to continue to work with a topflight team to create new levels of R&D Productivity for companies in Life Sciences and bring much needed treatments to the market for those who need them.”
About Advanced Clinical: Advanced Clinical provides consulting services, strategic sourcing (CRO), talent management, and technology solutions to the Life Sciences industry. With 15+ years of experience, Advanced Clinical is an established presence in the clinical research field, providing services specifically for Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device organizations. Advanced utilizes a value-based, “One Team” approach. To learn more, visit http://www.advancedclinical.com/.
Contact:
Rosemarie Truman
rtruman@advancedclinical.com
1200 Lakeside Drive
Bannockburn, IL 60015
Ph: 202-438-2208
Thursday, September 9, 2010
Advanced Clinical is Making a Difference in Talent Management
We are pleased to provide vital talent for companies and meaningful career opportunities for clinical research professionals.
We offer talent management services through contract staffing, direct hire placement, executive search, and payrolling (“asset transfer”). These different talent acquisition paths allow Advanced Clinical to effectively and efficiently connect talent to career opportunities within the clinical research industry. Our ability to provide and manage talent directly impacts their clients’ R&D success. For candidates, we offer a “career platform,” giving them not only employment, but also the chance to:
• Make a difference
• Become a star
• Provide insight
• Be part of an exceptional, topflight team
• Pursue their dreams
• Grow personally and professionally
Some of our consultants’ experiences are described below:
Tim, whom we placed as a Clinical Project Manager, said, “[Advanced Clinical is] very much focused on building relationships, finding out where my interests lie, and where my needs are.”
Buddy, whom we placed into Clinical Data Management, said, “I’ve been very pleased to work with Advanced Clinical because I feel that they are very well connected and understand the industry. Advanced Clinical has helped me not just find the next gig, but they have helped build my career.”
See live examples of our refreshing approach to talent management and career placement: http://www.youtube.com/user/advancedclinicaljobs#p/u/7/WCM-KdbGmE4
Advanced Clinical believes that creating positive experiences for candidates is cornerstone to building a vibrant, loyal workforce. Successful talent management positively impacts clinical research companies through lower overhead, more productive teams, and stronger retention of critically needed talent.
To learn more, visit http://www.advancedclinical.com
Wednesday, September 8, 2010
Writing the Future of Clinical Research
The past several years have seen the rapid growth of the Medical Writing field, with the market more than doubling from an estimated $345 million in 2003 to $694 million in 2008, according to a Centerwatch Monthly report. Membership in the American Medical Writers Association, which sets the profession’s standards, increased 14% in the same time to nearly 5,700 members globally. Additionally, two dozen colleges and universities have recently established either certificate or degree programs in medical or scientific communication. Across the industry, Medical Writers are being highly prized for their ability to communicate scientific data effectively and efficiently, as well as taking on additional roles, such as transnational trial coordination and quality assurance, in the drug development process.
What do Medical Writers do?
Medical Writers both have a thorough background in scientific areas and are adept at communicating this information to various audiences. They perform numerous important functions, including the following:
• Communicate scientific and clinical data to a range of audiences in a wide variety of formats
• Combine scientific knowledge and their research skills to present information for targeted audiences
• Write clinical trial protocols, clinical study reports, and other documents for submission to the FDA
• Prepare journal articles, conference posters/presentations, internet content, and training/marketing materials
Is Medical Writing for me?
Before you consider entering the Medical Writing field, know that there are several key attributes that make the field a fit for individuals:
• Interest in scientific fields and writing
• Excellent written and oral communication skills
• High-level detail orientation
• Good interpersonal skills and “team player” attitude
• Ability to multi-task, learn “on-the-job”, and meet project deadlines
Additionally, Medical Writers are expected to have a level of technical knowledge and skills such as:
• Current scientific writing and editing techniques
• Software and systems, such as document management software, Microsoft Office suite, as well as reference, literature, and publishing software
• Company policies, procedures, and tools
• Industry guidelines
• Scientific area background with statistical knowledge preferred
Who do Medical Writers work for?
• Pharmaceutical companies
• Medical communication agencies
• Contract Research Organizations (CRO)
• Freelance Publishers
• Academic Medical Centers, Medical Associations, Publishers, Magazines, Websites
What are the benefits?
• High involvement with the latest scientific research and information
• Rewarding work that makes a difference
• Can have flexible work hours
• Current high market demand for Medical Writers
• A number of opportunities for career development
• High entry level compensation (~$50-60,000) and employee benefits
• Flexibility to switch jobs
What jobs are available?
Advanced Clinical has a number of exciting Medical Writing opportunities available across a wide range of experience, including:
Senior Medical Writing Program Manager (Oncology) – Northern Suburbs of Chicago, Illinois
One of our clients is seeking a Senior Medical Writing Program Manager (Oncology) also known as Global Medical Writing Lead, generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects.
The individual will provide:
• Project leadership with respect to program documents and writing activities commensurate with experience
• Review of work and manage/coordinate writing activities across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document
• Intellectual leadership and contributes document knowledge and expertise to the project team
Associate Director, Medical Writing – Princeton, New Jersey
A client in the Princeton NJ area is looking to add a permanent Associate Director of Medical Writing to their team.
The individual’s responsibilities include:
• Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects
• Prepare clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format
• Coordinate and prepare Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports
Senior Medical Writers/Writing Team Leaders – Worldwide
A client is seeking experienced medical writers to serve as Team Leaders at their office locations around the world.
Team Leaders are strategic consultants, project leaders, and hands-on writers who:
• Serve as subject-matter experts for clients, guiding and advising them on strategies and best practices for achieving approval from health authorities
• Serve as subject-matter experts for team writers, providing leadership, advice, and continual mentoring
• Actively participate in development and writing of documents
• Ensure quality, adherence to budgets and timelines, and compliance with SOPs, policies, and other guidance as required by the company, regulatory bodies, and individual clients
See www.advancedclinical.com
What do Medical Writers do?
Medical Writers both have a thorough background in scientific areas and are adept at communicating this information to various audiences. They perform numerous important functions, including the following:
• Communicate scientific and clinical data to a range of audiences in a wide variety of formats
• Combine scientific knowledge and their research skills to present information for targeted audiences
• Write clinical trial protocols, clinical study reports, and other documents for submission to the FDA
• Prepare journal articles, conference posters/presentations, internet content, and training/marketing materials
Is Medical Writing for me?
Before you consider entering the Medical Writing field, know that there are several key attributes that make the field a fit for individuals:
• Interest in scientific fields and writing
• Excellent written and oral communication skills
• High-level detail orientation
• Good interpersonal skills and “team player” attitude
• Ability to multi-task, learn “on-the-job”, and meet project deadlines
Additionally, Medical Writers are expected to have a level of technical knowledge and skills such as:
• Current scientific writing and editing techniques
• Software and systems, such as document management software, Microsoft Office suite, as well as reference, literature, and publishing software
• Company policies, procedures, and tools
• Industry guidelines
• Scientific area background with statistical knowledge preferred
Who do Medical Writers work for?
• Pharmaceutical companies
• Medical communication agencies
• Contract Research Organizations (CRO)
• Freelance Publishers
• Academic Medical Centers, Medical Associations, Publishers, Magazines, Websites
What are the benefits?
• High involvement with the latest scientific research and information
• Rewarding work that makes a difference
• Can have flexible work hours
• Current high market demand for Medical Writers
• A number of opportunities for career development
• High entry level compensation (~$50-60,000) and employee benefits
• Flexibility to switch jobs
What jobs are available?
Advanced Clinical has a number of exciting Medical Writing opportunities available across a wide range of experience, including:
Senior Medical Writing Program Manager (Oncology) – Northern Suburbs of Chicago, Illinois
One of our clients is seeking a Senior Medical Writing Program Manager (Oncology) also known as Global Medical Writing Lead, generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects.
The individual will provide:
• Project leadership with respect to program documents and writing activities commensurate with experience
• Review of work and manage/coordinate writing activities across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document
• Intellectual leadership and contributes document knowledge and expertise to the project team
Associate Director, Medical Writing – Princeton, New Jersey
A client in the Princeton NJ area is looking to add a permanent Associate Director of Medical Writing to their team.
The individual’s responsibilities include:
• Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects
• Prepare clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format
• Coordinate and prepare Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports
Senior Medical Writers/Writing Team Leaders – Worldwide
A client is seeking experienced medical writers to serve as Team Leaders at their office locations around the world.
Team Leaders are strategic consultants, project leaders, and hands-on writers who:
• Serve as subject-matter experts for clients, guiding and advising them on strategies and best practices for achieving approval from health authorities
• Serve as subject-matter experts for team writers, providing leadership, advice, and continual mentoring
• Actively participate in development and writing of documents
• Ensure quality, adherence to budgets and timelines, and compliance with SOPs, policies, and other guidance as required by the company, regulatory bodies, and individual clients
See www.advancedclinical.com
Wednesday, August 25, 2010
Chart Your Path: Insight from an Accomplished Drug Development Expert
Gil Price – a physician who has worked with some of the largest pharmaceutical companies and has built two companies himself – has critical guidance for individuals charting their career path:
"The best advice I can give to anyone starting out in the life sciences industry, or any industry, is that you must be able to communicate effectively across multiple lines of management. You have to be able to speak to the CEO as well as the janitor. You need to be able to motivate individuals who have zero stake in your success, and get them to perform on your behalf. If you can’t do that, you will not be successful in any line of work."
While education, technical expertise and work style are all vital in a career path, the lack of ability to communicate with co-workers, management, patients, personnel, and/or the public, can leave your career growth unexpectedly stunted.
When involved in clinical trials, a number of critical people are involved on the path to drug development. Not only might there be communication issues, but another major challenge is drug supply, specifically if the drug is hard to manufacture. This means you will need the manufacturing group to collaborate with you on the way to getting the drug produced.
Background and Training Shapes Your Career’s Success
Communication is key, and so is training. Price received training in Big Pharma early in his career. When he was starting out, GlaxoSmithKline (GSK) presented him with an enticing offer to come on board. At GSK, the executive who hired Gil was also a magnificent mentor. Price was placed into a variety of positions that covered all aspects of drug development, manufacturing, basic sciences and regulatory, a type of training that may be difficult to find in a smaller biotech company, often only existing in large pharmaceutical companies. He calls this time of his career "an 11-½ year internship."
After leaving GSK, Price went to work at Quintiles as executive vice president, with an assurance from the CEO to work more with public markets. He worked with clinical trials for four years and, during this time, Quintiles expanded and acquired several companies in Europe. A former colleague from GSK then called him about an opportunity at MedImmune.
Due to his experience at GSK, Price was given the tremendous opportunity to work on multiple product launches and new invitations for old products. He worked on medical affairs in an umbrella department that was largely responsible for all post-marketing activities involved in commercial drug development, post-marketing pharmacovigilance, post-marketing clinical studies, drug information and publication responsibilities.
After MedImmune is when Price carved out his entrepreneurial career. First, he started his own biotechnology company. He pulled a team together and raised money, then 26 months later, sold the company to a private group on the west coast. Next, he started Drug Safety Solutions, for which he is currently owner, providing services to biotechnology and pharmaceutical companies for all aspects of pharmacovigilance.
Insight and Advice to Further Your Career Path
Price has advice for future entrepreneurs: "If you ever want to be entrepreneurial, being part of a small biotechnology company is an important experience to have."
Although barriers are in every career, they are expected, and will vary with each position. A major barrier in this industry, says Price, may be that the world can throw you a curveball: "All of a sudden, you are basing decisions on the idea that a drug is going to work. Sometimes a drug just doesn't work, even if you perform everything appropriately. Of course you try to discover this as early as possible so you can 'kill' a failing drug quickly. By that time, however, you’ve spent millions of dollars, only to see it go up in flames."
What does Price recommend to someone trying to figure out what next steps to take to chart his/her path?
"It is important to reach out to colleagues who have been successful. Communicate with others who fall under your umbrella of interest so that you can understand what a proper path looks like."
There are many individuals, he says, who have limited interaction with the broader community in conferences, such as Association of Clinical Research Professionals (ACRP) meetings. Many focus on meetings in their particular therapeutic area, such as a cardiology conference. However, staying so narrowly focused eliminates the individual from networking with other drug development physicians and professionals.
While you can never over-expand your network, working in the life sciences industry has significant benefits over many other career paths:
"What this path allows you to do is to potentially impact the health of millions. Your career path has the aspect of being intellectually stimulating and cutting edge where you can affect the lives and well being of thousands of patients."
Let Advanced Clinical keep you on track: advance your path to a rewarding career. See www.advancedclinical.com
"The best advice I can give to anyone starting out in the life sciences industry, or any industry, is that you must be able to communicate effectively across multiple lines of management. You have to be able to speak to the CEO as well as the janitor. You need to be able to motivate individuals who have zero stake in your success, and get them to perform on your behalf. If you can’t do that, you will not be successful in any line of work."
While education, technical expertise and work style are all vital in a career path, the lack of ability to communicate with co-workers, management, patients, personnel, and/or the public, can leave your career growth unexpectedly stunted.
When involved in clinical trials, a number of critical people are involved on the path to drug development. Not only might there be communication issues, but another major challenge is drug supply, specifically if the drug is hard to manufacture. This means you will need the manufacturing group to collaborate with you on the way to getting the drug produced.
Background and Training Shapes Your Career’s Success
Communication is key, and so is training. Price received training in Big Pharma early in his career. When he was starting out, GlaxoSmithKline (GSK) presented him with an enticing offer to come on board. At GSK, the executive who hired Gil was also a magnificent mentor. Price was placed into a variety of positions that covered all aspects of drug development, manufacturing, basic sciences and regulatory, a type of training that may be difficult to find in a smaller biotech company, often only existing in large pharmaceutical companies. He calls this time of his career "an 11-½ year internship."After leaving GSK, Price went to work at Quintiles as executive vice president, with an assurance from the CEO to work more with public markets. He worked with clinical trials for four years and, during this time, Quintiles expanded and acquired several companies in Europe. A former colleague from GSK then called him about an opportunity at MedImmune.
Due to his experience at GSK, Price was given the tremendous opportunity to work on multiple product launches and new invitations for old products. He worked on medical affairs in an umbrella department that was largely responsible for all post-marketing activities involved in commercial drug development, post-marketing pharmacovigilance, post-marketing clinical studies, drug information and publication responsibilities.
After MedImmune is when Price carved out his entrepreneurial career. First, he started his own biotechnology company. He pulled a team together and raised money, then 26 months later, sold the company to a private group on the west coast. Next, he started Drug Safety Solutions, for which he is currently owner, providing services to biotechnology and pharmaceutical companies for all aspects of pharmacovigilance.
Insight and Advice to Further Your Career Path
Price has advice for future entrepreneurs: "If you ever want to be entrepreneurial, being part of a small biotechnology company is an important experience to have."
Although barriers are in every career, they are expected, and will vary with each position. A major barrier in this industry, says Price, may be that the world can throw you a curveball: "All of a sudden, you are basing decisions on the idea that a drug is going to work. Sometimes a drug just doesn't work, even if you perform everything appropriately. Of course you try to discover this as early as possible so you can 'kill' a failing drug quickly. By that time, however, you’ve spent millions of dollars, only to see it go up in flames."
What does Price recommend to someone trying to figure out what next steps to take to chart his/her path?
"It is important to reach out to colleagues who have been successful. Communicate with others who fall under your umbrella of interest so that you can understand what a proper path looks like."
There are many individuals, he says, who have limited interaction with the broader community in conferences, such as Association of Clinical Research Professionals (ACRP) meetings. Many focus on meetings in their particular therapeutic area, such as a cardiology conference. However, staying so narrowly focused eliminates the individual from networking with other drug development physicians and professionals.
While you can never over-expand your network, working in the life sciences industry has significant benefits over many other career paths:
"What this path allows you to do is to potentially impact the health of millions. Your career path has the aspect of being intellectually stimulating and cutting edge where you can affect the lives and well being of thousands of patients."
Let Advanced Clinical keep you on track: advance your path to a rewarding career. See www.advancedclinical.com
Thursday, July 29, 2010
Design Your Dream Job Contest: What Should You Expect to Get from your Dream Job?
Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing companies have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.
“What Should You Expect?”
The best companies will provide the opportunity to grow your career, challenge yourself and allow you to provide insight and a point of view. The company as well as the job itself should offer a positive and challenging environment to help cultivate your skill set. Here is the top list of things that you should expect when you get a job.
Make a difference.
You should have the chance to make a difference in clinical research, helping bring drugs to market.
Have your ideas heard.
The company should allow you to showcase your expertise to further the Life Sciences field, creating new efficiencies and effectiveness in companies based on experience.
Become a Star.
While working at a company, they should have resources to get your name out there. You should have plenty of opportunities to effectively market yourself and your abilities to the Life Sciences industry
Be CHALLENGED.
Learn new skills and encounter new opportunities with their breadth and depth of available work experiences.
Be Part of a Community.
Beyond just exchanging information with each other, the company should have an elite team and consultant community that collaborates. Look for an extensive alumni program, superior benefits and a comprehensive loyalty program.
Pursue your Dreams.
Make sure you are truly happy at your workplace and can maintain an optimal work and life balance. Accommodating your personal preferences and career goals goes hand in hand.
Grow!
Understand your desired career path and ensure that you have job opportunities that help you build your skills in your desired direction. There should be sufficient intellectual capital that will help you get best practices experience every day.
These seven points were developed and are currently utilized by Advanced Clinical’s “AC Experience” framework for its consultants. We expect our consultants to work at the highest level possible, and we provide them with the opportunity and environment to do so.
So… “What's Your Dream Job?"
World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.
The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.
You can enter by submitting a description of your dream job, a video, or any other creative form.
Enter to win …August 17th is the new date we will choose a winner!
See www.advancedclinical.com
Friday, July 9, 2010
Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs
Although adaptive designs produce numerous benefits for clinical trials, there are also a number of risks associated with it. Below, Advanced Clinical outlines some of the key risks when conducting adaptive designs as well as ways people mitigate them. Also are some FDA-accepted designs, including the more well known Bayesian approach.
What are the big, key risks?
One major concern is the effect of adaptive designs on statistical measures. Though addressed broadly, the issue of preservation of type I error rate remains a key issue in adaptive design. Also, changes in sample size, hypotheses, and other statistical measures affect the validity of the outcome data in clinical trials. Logistic concerns include methods on how to collect data. With interim decision making, data must be collected rapidly, and with short follow-up times in order for that data to remain relevant to the current state of the study. The main procedural issue to be followed closely relates to data review, careful decision making, and implementation of decisions during adaptive trials while maintaining trial integrity.
click picture for full view!
How do you mitigate those risks?
To mitigate risks that come with adaptive design, careful planning pre-clinical trial must take place. The right statistical measures must be in place and through simulation, the right statistical changes must be determined in case interim data suggests changes on statistical procedures. During clinical trials, it is recommended to have a Data Monitoring Committee (DMC) to review interim results and determine whether relative changes can be made. Also during trials, the use of clinical technologies such as EDC, IVRS and IWRS as well as light EDC are highly recommended in order to deal with the logistic concern of quick, responsive data analysis.
Some commonly accepted designs approved by the FDA (click picture for full view!)
Bayesian Adaptive Dose Allocation Approach (click picture for full view!)
See www.advancedclinical.com
Wednesday, July 7, 2010
Advancing Discoveries: Adaptive Designs in Clinical Trials
What is Adaptive?
In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!
Why do it?
Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.
Types of Adaptive Design Options (click picture to view!)
With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.
What are the Pros and Cons of Adaptive Design? (click picture to view!)
Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.
Also, don't forget to add our facebook page! www.facebook.com/advclinical
See www.advancedclinical.com
Monday, June 21, 2010
DIA Conference Recap: Come join our discussion!
Advanced Clinical attended the DIA conference June 13-17th, 2010 in downtown DC at the Washington Convention Center. It was an awesome week. We were able to meet so many people, while networking, brainstorming, and discussing numerous topics surrounding the clinical and pharmaceutical industry.
Our team was able to sit in on and discuss many interesting presentations. The one presentation that really hit it for us was the session “Fiscally Responsible Protocol Development: Minimizing Potholes and Avoiding Sinkholes” hosted by Anna Hindle, Anne Cropp and Ken Getz. The session outlined:
a) The financial impact of protocol amendments including the hidden costs
b) Protocol amendments correlation with therapeutic areas and functional areas, e.g., data management, clinical operations, etc.
c) Triggers/causes of protocol amendments
d) Characteristics of protocols that generate lots of amendments, e.g., the more Investigator sites, the more amendments
e) Amendments that are avoidable and amendments that are not avoidable
f) Lessons learned and tips / techniques for circumventing / preventing the avoidable amendments
Some interesting facts about amendments we learned: 40% of amendments occur before the first patient is in, 631 hours/amendment approval, 484 hours/amendment to implement, and a minimum of $60K per amendment - $400K per amendment. We also learned that the key triggers of amendments were due to: standard of care changes, safety issues, and the need to deal with sub-populations.
Advanced Clinical had some additional thoughts on the amendment front upon reflecting on this presentation:
a) Would be good to determine the characteristics of a good amendment and a “bad amendment”
b) It’s important to perform the analysis of doing the amendment vs. not doing the amendment
c) Perhaps consider the following items to deal with amendments more efficiently:
- Think about doing amendments in “release” schedules like people do in software development
- Use tools that allow standard language document components – there are some good document management tools that have this functionality
- Create guidelines for the organization to evaluate whether or not an amendment should be performed
- Understand the causes of amendments in your organization. Gather data around amendments for therapeutic area; cause; sub-population; hours to design/gain approval for amendment; hours to implement amendment
- Create an ecosystem of experts to review the protocol before finalizing it to avoid amendments. Put more time into the protocol up front to ensure completeness and consideration of key areas where changes could occur
- Make the language more flexible in the protocol to avoid the amendment, e.g., put in “5-9 sites” instead of “7 sites”
On top of the presentations, the exhibitions were excellent. Our favorite was Oracle’s demonstration of their new Oracle Clinical product. We were able to talk with Oracle and their product roadmap as it relates to their EDC product, “RDC”. Also we were able to discuss Oracle Clinical’s “big picture architecture including IVRS, IWRS, EDC, Business intelligence as well as the anchor Oracle Clinical Product.
Were there any presentations or exhibitions you particularly enjoyed or thought was informational? What are some of your thoughts on the presentations given? Hanging questions? Comments? Please let us know! Come join our discussion and comment or write on our wall in our Blog or on our Facebook page. We’d love to hear your ideas and takeaways from the DIA Conference.
AC also had the opportunity to host OYA for a networking happy hour. It was a huge success! We were able to gather so many great people from the DIA Conference. There was a lot of relaxing, socializing and brainstorming for advancing discoveries. If you weren’t able to make it, please join our discussion for Advancing Discoveries on our Facebook page at www.facebook.com/AdvClinical
See www.advancedclinical.com
Wednesday, June 16, 2010
Men’s Health and Cancer Awareness Week
With Father's Day coming up this Sunday, June 20, it also marks the week for men's health and cancer awareness. See our blog post on women's cancer awareness week.
Due to a lack of awareness, poor health education and culturally induced behavioral patterns in their work and personal lives, men’s health and well being are deteriorating rapidly. Statistics show that men live sicker and die younger than American women. Men’s Health Week is to bring awareness to the fact that men can do things to prevent suffering and even dying from many avoidable and treatable diseases. It is important for men to pay attention to their bodies and visit a doctor whenever suspicious symptoms arise. Annual physicals are recommended to ensure proper screenings are done. Early detection and treatment of disease is extremely important to maximize your health. To download a Blueprint For Men’s Heath – a publication that discusses the main health issues that men face today – click on this link here.
Best wishes to all Fathers this coming Sunday. To quote Congressman Bill Richardson (Congressional Record, H3905-H39906, May 24, 1994):
“Recognizing and preventing men’s health problems is not just a man’s issue. Because of its impact on wives, mothers, daughters, and sisters, men’s health is truly a family issue.”
Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Clinicians are a part of this discovery process, so it's important that your needs as an employee are met, too. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
See www.advancedclinical.com
Due to a lack of awareness, poor health education and culturally induced behavioral patterns in their work and personal lives, men’s health and well being are deteriorating rapidly. Statistics show that men live sicker and die younger than American women. Men’s Health Week is to bring awareness to the fact that men can do things to prevent suffering and even dying from many avoidable and treatable diseases. It is important for men to pay attention to their bodies and visit a doctor whenever suspicious symptoms arise. Annual physicals are recommended to ensure proper screenings are done. Early detection and treatment of disease is extremely important to maximize your health. To download a Blueprint For Men’s Heath – a publication that discusses the main health issues that men face today – click on this link here.
Best wishes to all Fathers this coming Sunday. To quote Congressman Bill Richardson (Congressional Record, H3905-H39906, May 24, 1994):
“Recognizing and preventing men’s health problems is not just a man’s issue. Because of its impact on wives, mothers, daughters, and sisters, men’s health is truly a family issue.”
Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Clinicians are a part of this discovery process, so it's important that your needs as an employee are met, too. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
See www.advancedclinical.com
Thursday, June 10, 2010
Advanced Clinical: The CRO with Experienced Employees
Advanced Clinical has advanced many discoveries and has experience in over 192 trials in many therapeutic areas across Phases 1 though 4. Over the years, we've worked together with pharmaceutical companies to enhance medicine in disciplines which include but are not limited to:
1. Analgesia
2. Anti-Infective
3. Antiviral
4. Cardiology
5. Endocrinology
6. Gastrointestinal*
7. Geriatrics
8. Gynecology*
9. Hematology
10. Infectious Disease
11. Infertility
12. Musculoskeletal
13. Neurology
14. Oncology
15. Urology
16. Ophthalmology
17. Renal
18. Respiratory
19. Rheumatology*
20. Women's Health
*Advanced Clinical has over 25 trials' experience in these indicated disciplines.
Of our 192 trials, a whopping 191 of them used Advanced Clinical's Data Management service. Our Data Management service is reliable, resilient, and depended on by the best pharmaceutical, biotech and medical device companies in the industry. Our technology platform utilizes state-of-the-art tools: Oracle Clinical, Electronic Data Capture (EDC), and IVRS and IWRS (Interactive Voice or Web Response Systems).
Advanced Clinical also adheres to CDISC and SDTM standards with integrity checks and trial monitoring reports. Advanced Clinical is compliant with ICH, the FDA (21 CFR part 11) and GCP.
Our Biostatistics team is among the best in the nation and we continue to add strength and capabilities to the team in strategic therapeutic areas.
Advanced Clinical is prepared to handle any size trial. Within our body of work, 15 percent had over 500 subjects; one of those trials had over 5,000. We've done trials within the US at one site, and globally over hundreds of sites. Whatever your trial needs are, we will develop a plan and do our part to partner in your development.
Advanced Clinical's leading practices help drive the speed, improve the quality, and ensure the highest probability of success at the lowest total cost of ownership. Some of the delivery assets we use are:
• Our approach to collaborate, innovate, and optimize. Advanced Clinical believes in working together in collaboration, innovation through the Industry Leading R&D Process, and maintaining a continuous learning approach to optimize trials.
• Resource Management Model. Advanced Clinical not only retains, but nurtures our consultants to keep the best ones loyal and available for our exciting projects.
• Team Integration. Advanced Clinical wants to make the client team and the Advanced Clinical team integrated into one.
• Risk Management. Advanced Clinical identifies, assesses, prioritizes, mitigates, and tracks risks to proactively avoid issues that might arise
• Continuous Learning. Continually improving the trial as it goes on will optimize its overall success.
• Ramping. Advanced Clinical onboards, trains, and adapts the team to the client's environment, culture, project and needs.
• Project Management with Supply / Demand Management. Advanced Clinical will ensure clients get the right team, at the right time, and with optimal productivity with collaborative project management.
Use a clinical research organization with experience and an approach to support your growth: Advanced Clinical.
Our employees are well-versed in all of the above areas, and we take great care of them. If you want to have a more fulfilling job, check out our design your dream job contest: you may win a $200 gift certificate and also get your dream job!
See www.advancedclinical.com
1. Analgesia
2. Anti-Infective
3. Antiviral
4. Cardiology
5. Endocrinology
6. Gastrointestinal*
7. Geriatrics
8. Gynecology*
9. Hematology
10. Infectious Disease
11. Infertility
12. Musculoskeletal
13. Neurology
14. Oncology
15. Urology
16. Ophthalmology
17. Renal
18. Respiratory
19. Rheumatology*
20. Women's Health
*Advanced Clinical has over 25 trials' experience in these indicated disciplines.
Of our 192 trials, a whopping 191 of them used Advanced Clinical's Data Management service. Our Data Management service is reliable, resilient, and depended on by the best pharmaceutical, biotech and medical device companies in the industry. Our technology platform utilizes state-of-the-art tools: Oracle Clinical, Electronic Data Capture (EDC), and IVRS and IWRS (Interactive Voice or Web Response Systems).
Advanced Clinical also adheres to CDISC and SDTM standards with integrity checks and trial monitoring reports. Advanced Clinical is compliant with ICH, the FDA (21 CFR part 11) and GCP.
Our Biostatistics team is among the best in the nation and we continue to add strength and capabilities to the team in strategic therapeutic areas.
Advanced Clinical is prepared to handle any size trial. Within our body of work, 15 percent had over 500 subjects; one of those trials had over 5,000. We've done trials within the US at one site, and globally over hundreds of sites. Whatever your trial needs are, we will develop a plan and do our part to partner in your development.
Advanced Clinical's leading practices help drive the speed, improve the quality, and ensure the highest probability of success at the lowest total cost of ownership. Some of the delivery assets we use are:
• Our approach to collaborate, innovate, and optimize. Advanced Clinical believes in working together in collaboration, innovation through the Industry Leading R&D Process, and maintaining a continuous learning approach to optimize trials.
• Resource Management Model. Advanced Clinical not only retains, but nurtures our consultants to keep the best ones loyal and available for our exciting projects.
• Team Integration. Advanced Clinical wants to make the client team and the Advanced Clinical team integrated into one.
• Risk Management. Advanced Clinical identifies, assesses, prioritizes, mitigates, and tracks risks to proactively avoid issues that might arise
• Continuous Learning. Continually improving the trial as it goes on will optimize its overall success.
• Ramping. Advanced Clinical onboards, trains, and adapts the team to the client's environment, culture, project and needs.
• Project Management with Supply / Demand Management. Advanced Clinical will ensure clients get the right team, at the right time, and with optimal productivity with collaborative project management.
Use a clinical research organization with experience and an approach to support your growth: Advanced Clinical.
Our employees are well-versed in all of the above areas, and we take great care of them. If you want to have a more fulfilling job, check out our design your dream job contest: you may win a $200 gift certificate and also get your dream job!
See www.advancedclinical.com
Thursday, June 3, 2010
Contest Extended Through July
NOW--Extended through July:
"What's Your Dream Job?"
"What's Your Dream Job?"
Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.
World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “Design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.
The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.
You can enter with a description of your dream job, a video, or any other creative form.
What's your dream job?
For winners announcement, you can follow Advanced Clinical on facebook or on one of our social networks:
- http://www.facebook.com/pages/Advanced-Clinical-Jobs/312691418900?v=wall&ref=ts
- http://twitter.com/AdvClinicalJobs
- http://youtube.com/AdvancedClinicalJobs
- http://advancedclinicaljobs.blogspot.com/
- http://advancedclinicaljobs.wordpress.com/
See www.advancedclinical.com
Job Opening -- VP Advanced Clinical
Job Title: Vice-President
Reports To: Chief Executive Officer
FLSA Status: Exempt
Prepared By: Kimberly Marzano (email)
Prepared Date: 5/12/2010
SUMMARY
The Vice President will serve as head of the local biometrics contract research organization (“CRO”), with the ultimate responsibility of achieving established strategic, operational, and financial objectives, both short-term and long-term. The VP will be involved in all aspects of the business, including strategic planning; resource planning, management, and utilization; operations and quality management; business development; and budgeting and financial planning. The VP will have 4 to 6 direct reports who will comprise the management team. The team, particularly vis a vis the leadership skill of the VP, will be expected to foster a unique culture and work environment that will consistently drive both outstanding business performance and exceptional employee satisfaction.
PRIMARY AREAS OF RESPONSIBILITY include the following:
* Thoroughly understand and embody the vision, mission, and values of the company.
* Establish a professional leadership presence with all internal and external constituencies, which instills respect, confidence, and trust.
* Coordinate assignments of resources and projects across teams and ensure all teams stay on target.
* Develop and maintain competency framework, training programs, and attract and retain employees to foster best in class clinical operations.
* Through leadership style, develop a positive and enthusiastic culture with optimal communications.
* Promote a work environment where staff operates with a high sense of accountability, thereby allowing individual, team, and company goals to consistently be met.
* Identify business improvement opportunities and participate and/or lead in creating solutions which improve the client’s efficiency and effectiveness.
* Ensure that all client SOPs are adhered to and federal regulations are followed with respect to each client.
* Ensure that all vendor contracts appropriately delineate the responsibilities of the various parties involved in the clinical study.
* Conduct services meetings with current clients to gather feedback and maintain relationships.
* Work closely with the CEO and CFO on financial matters, including contract negotiations, budgeting, forecasting, and accounts receivable excellence.
* Work closely with the CEO, CFO, and the management team on executing the business strategy, to maximize revenue and profit growth and, ultimately, shareholder value.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* 5-7 years of relevant experience in a CRO, managing other staff members
* 15 years in CRO environment
* Masters or PhD preferred
* Strong written, oral communication and presentation skills with excellent interpersonal skills
* Good Clinical Practices (GxP Regulations; ICH guidelines; Good Quality Practices)
* Excellent problem solving skills in highly complex situations
* Exceptional time management skills. Able to balance many competing priorities with grace.
* Good negotiating skills
* Excellent judgment and decision making skills
* Leadership and line management skills with a balanced management approach which promotes collaboration and teamwork
* Management style that empowers employees
* Intellectually, emotionally, and logically smart. Well-grounded with solid common sense and direct approach that effectively deals with a broad range of people, backgrounds, and skill levels.
* Ability to establish and maintain effective working relationships with co-workers, managers and clients
* Team player and proven team builder. Good facilitator and collaborator. Persuasive. Can focus and continuously reinforce managements’ efforts to meet their goals.
* Ability to identify business improvement opportunities and to then effectively implement and institutionalize those improvements
* Able to analyze business intelligence and reports and to synthesize such information into action.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
See www.advancedclinical.com
Reports To: Chief Executive Officer
FLSA Status: Exempt
Prepared By: Kimberly Marzano (email)
Prepared Date: 5/12/2010
SUMMARY
The Vice President will serve as head of the local biometrics contract research organization (“CRO”), with the ultimate responsibility of achieving established strategic, operational, and financial objectives, both short-term and long-term. The VP will be involved in all aspects of the business, including strategic planning; resource planning, management, and utilization; operations and quality management; business development; and budgeting and financial planning. The VP will have 4 to 6 direct reports who will comprise the management team. The team, particularly vis a vis the leadership skill of the VP, will be expected to foster a unique culture and work environment that will consistently drive both outstanding business performance and exceptional employee satisfaction.
PRIMARY AREAS OF RESPONSIBILITY include the following:
* Thoroughly understand and embody the vision, mission, and values of the company.
* Establish a professional leadership presence with all internal and external constituencies, which instills respect, confidence, and trust.
* Coordinate assignments of resources and projects across teams and ensure all teams stay on target.
* Develop and maintain competency framework, training programs, and attract and retain employees to foster best in class clinical operations.
* Through leadership style, develop a positive and enthusiastic culture with optimal communications.
* Promote a work environment where staff operates with a high sense of accountability, thereby allowing individual, team, and company goals to consistently be met.
* Identify business improvement opportunities and participate and/or lead in creating solutions which improve the client’s efficiency and effectiveness.
* Ensure that all client SOPs are adhered to and federal regulations are followed with respect to each client.
* Ensure that all vendor contracts appropriately delineate the responsibilities of the various parties involved in the clinical study.
* Conduct services meetings with current clients to gather feedback and maintain relationships.
* Work closely with the CEO and CFO on financial matters, including contract negotiations, budgeting, forecasting, and accounts receivable excellence.
* Work closely with the CEO, CFO, and the management team on executing the business strategy, to maximize revenue and profit growth and, ultimately, shareholder value.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* 5-7 years of relevant experience in a CRO, managing other staff members
* 15 years in CRO environment
* Masters or PhD preferred
* Strong written, oral communication and presentation skills with excellent interpersonal skills
* Good Clinical Practices (GxP Regulations; ICH guidelines; Good Quality Practices)
* Excellent problem solving skills in highly complex situations
* Exceptional time management skills. Able to balance many competing priorities with grace.
* Good negotiating skills
* Excellent judgment and decision making skills
* Leadership and line management skills with a balanced management approach which promotes collaboration and teamwork
* Management style that empowers employees
* Intellectually, emotionally, and logically smart. Well-grounded with solid common sense and direct approach that effectively deals with a broad range of people, backgrounds, and skill levels.
* Ability to establish and maintain effective working relationships with co-workers, managers and clients
* Team player and proven team builder. Good facilitator and collaborator. Persuasive. Can focus and continuously reinforce managements’ efforts to meet their goals.
* Ability to identify business improvement opportunities and to then effectively implement and institutionalize those improvements
* Able to analyze business intelligence and reports and to synthesize such information into action.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
See www.advancedclinical.com
Friday, May 21, 2010
Big Pharma aims for reinvention
With some of his most profitable medicines going off patent, and the uncertainty of replacement drugs continuing to rise, US healthcare reform has been the least of Andrew Witty’s recent worries.
When the chief executive of GlaxoSmithKline presented his company’s most recent financial results last month, he gave a sense of how the UK’s biggest drugmaker – and the industry more generally – is responding to structural pressures: diversify to survive.
For his company, he says, this means a shift away from “white pills in western markets”, with the proportion of traditionally core patent-protected, chemically based drugs, which are sold mainly in North America and western Europe, falling to just more than a quarter of total sales.
For many years, large companies such as GSK have relied on a handful of typically high-priced, mass-market “blockbusters” that generate billions of dollars a year in sales. But as patents expire on drugs such as Lipitor, Pfizer’s anti-cholesterol medicine that is the biggest selling medication in history, big pharma is having to rethink its business model.
Most large pharmaceutical companies have adopted four principal strategies to diversify. First, expand the range of products in the research and development pipeline and the use of external as well as in-house scientists to discover them. Second, expand geographically, especially into emerging markets. Third, increase sales of products other than patented prescription medicines. Fourth, experiment with greater flexibility in pricing in different countries and with ways to ensure drugs provide value for money.
Read the rest of the article -- FinancialTimes.com
Visit us at www.advancedclinical.com
When the chief executive of GlaxoSmithKline presented his company’s most recent financial results last month, he gave a sense of how the UK’s biggest drugmaker – and the industry more generally – is responding to structural pressures: diversify to survive.
For his company, he says, this means a shift away from “white pills in western markets”, with the proportion of traditionally core patent-protected, chemically based drugs, which are sold mainly in North America and western Europe, falling to just more than a quarter of total sales.
For many years, large companies such as GSK have relied on a handful of typically high-priced, mass-market “blockbusters” that generate billions of dollars a year in sales. But as patents expire on drugs such as Lipitor, Pfizer’s anti-cholesterol medicine that is the biggest selling medication in history, big pharma is having to rethink its business model.
Most large pharmaceutical companies have adopted four principal strategies to diversify. First, expand the range of products in the research and development pipeline and the use of external as well as in-house scientists to discover them. Second, expand geographically, especially into emerging markets. Third, increase sales of products other than patented prescription medicines. Fourth, experiment with greater flexibility in pricing in different countries and with ways to ensure drugs provide value for money.
Read the rest of the article -- FinancialTimes.com
Visit us at www.advancedclinical.com
Saturday, May 15, 2010
Risk Management from Advanced Clinical
Risk is a huge problem in clinical trials, and Advanced Clinical is swift and professional about identifying, assessing, prioritizing, mitigating and tracking risks to proactively avoid those risks – before they become issues that cause the trial to delay the trial. Some risks, unmitigated, can cause 2 years of delay!
Advanced Clinical:
o Assesses risks
o Prioritizes risks
o Reduces uncertainty
o Mitigates risks
o Manages/monitors risks
o Optimizes procedures to reverse risks
Advanced Clinical recognizes the four types of risk: operational, strategic, financial, and market, so no area is overlooked. Advanced Clinical also assesses the scale of the impact, and the likelihood of occurrence of the risk over the trial period.
We want success and advancement for your discovery's trial as much as you do, and managing and mitigating risks is one of our keys to success.
Our teams learn our risk management techniques. If you want to learn about them as well, check out our design your dream job contest: you may win a $200 gift certificate and also get your dream job!
See www.advancedclinical.com
Advanced Clinical:
o Assesses risks
o Prioritizes risks
o Reduces uncertainty
o Mitigates risks
o Manages/monitors risks
o Optimizes procedures to reverse risks
Advanced Clinical recognizes the four types of risk: operational, strategic, financial, and market, so no area is overlooked. Advanced Clinical also assesses the scale of the impact, and the likelihood of occurrence of the risk over the trial period.
We want success and advancement for your discovery's trial as much as you do, and managing and mitigating risks is one of our keys to success.
Our teams learn our risk management techniques. If you want to learn about them as well, check out our design your dream job contest: you may win a $200 gift certificate and also get your dream job!
See www.advancedclinical.com
Wednesday, May 12, 2010
Ramping and Onboarding with Advanced Clinical
Advanced Clinical's approach to onboarding, training, and adapting team to the client environment is a crucial key to trial acceleration. One week leading up to a trial, Advanced Clinical identifies potential team players, assessing their fit culturally and their competencies. The week of the trial, you interview the team members to gauge comfort level, then the employees engage in Advanced Clinical on-boarding / training, as well as your specific training. Many times, we try to prepare candidates for your trial in advance; therefore, we pre-screen candidates with you, and get them onboarded and trained, so that when you need them, they’re ready for you!
Also included in the rampup process are team “integration” sessions to clarify the plan/schedule, deliverables, roles, project handoffs as well as communication. AC also has team building activities to ensure that the teams will work harmoniously together and the team builds strong chemistry to ensure close collaboration.
Advanced Clinical wants to make sure all steps are taken to provide a “dream team” ready to work efficiently and effectively.
Advanced Clinical strives to make the best environment for our employees. We hope you like our ramping program. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
See www.advancedclinical.com
Also included in the rampup process are team “integration” sessions to clarify the plan/schedule, deliverables, roles, project handoffs as well as communication. AC also has team building activities to ensure that the teams will work harmoniously together and the team builds strong chemistry to ensure close collaboration.
Advanced Clinical wants to make sure all steps are taken to provide a “dream team” ready to work efficiently and effectively.
Advanced Clinical strives to make the best environment for our employees. We hope you like our ramping program. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
See www.advancedclinical.com
Tuesday, May 4, 2010
Women's Cancer Awareness Week
With Mother's Day around the corner on May 9, it also marks the week for women's health and cancer awareness.
In spite of social leaps and bounds women have made in recent decades, there are still distinct differences between the bodies of men and women. There are many cancers that affect only women, or mostly women: breast cancer, fallopian tube cancer, ovarian cancer, uterine cancer, vaginal cancer, and vulvar cancer. Birth control pills can put women at risk of breast tenderness, gall bladder disease, bloating, nausea, acne, and headaches. Women are more susceptible to mood disorders like depression and anxiety.
Women go through menopause. Here is a great article from Google about how to ease symptoms of menopause and what to expect.
It's not all that bad being a lady, though. Women typically have a larger deep limbic system than men, which allows them to be more in touch with feelings and better able to express those feelings, which promotes bonding and friendship with others. Women are also blessed with the gifts of childbirth and breastfeeding, which form immediate and permanent bonds with her child.
Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Clinicians are a part of this discovery process, so it's important that your needs as an employee are met, too. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
See www.advancedclinical.com
In spite of social leaps and bounds women have made in recent decades, there are still distinct differences between the bodies of men and women. There are many cancers that affect only women, or mostly women: breast cancer, fallopian tube cancer, ovarian cancer, uterine cancer, vaginal cancer, and vulvar cancer. Birth control pills can put women at risk of breast tenderness, gall bladder disease, bloating, nausea, acne, and headaches. Women are more susceptible to mood disorders like depression and anxiety.
Women go through menopause. Here is a great article from Google about how to ease symptoms of menopause and what to expect.
It's not all that bad being a lady, though. Women typically have a larger deep limbic system than men, which allows them to be more in touch with feelings and better able to express those feelings, which promotes bonding and friendship with others. Women are also blessed with the gifts of childbirth and breastfeeding, which form immediate and permanent bonds with her child.
Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Clinicians are a part of this discovery process, so it's important that your needs as an employee are met, too. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
See www.advancedclinical.com
Tuesday, April 27, 2010
Achieve Success with Continuous Learning
Advanced Clinical, the trusted CRO among the world's top pharmaceutical, biotechnology, and medical device companies, is enhancing Continuous Learning as a part of their Industry Leading Trial Performance method.
Advanced Clinical is experienced enough with trials to know that trials sometimes deviate from the original plan to improve scheduling, avoid risk, and improve efficiency and optimize the entire project. Continuous learning keeps everyone working on a trial up-to-date with those improvements. Change is not always good for a trial, but continuous learning and improvements means the right changes are being made.*
Continuous learning leads to success,** which is what AC wants its employees to achieve.
Does this sound like a good way to work? We think it is. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
Sources:
*Is Change Always Good In Business?, Brian Chernett, CEO of the Academy for Chief Executives .
**Success Made Simple, Erik Wesner.
See www.advancedclinical.com
Advanced Clinical is experienced enough with trials to know that trials sometimes deviate from the original plan to improve scheduling, avoid risk, and improve efficiency and optimize the entire project. Continuous learning keeps everyone working on a trial up-to-date with those improvements. Change is not always good for a trial, but continuous learning and improvements means the right changes are being made.*
Continuous learning leads to success,** which is what AC wants its employees to achieve.
Does this sound like a good way to work? We think it is. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!
Sources:
*Is Change Always Good In Business?, Brian Chernett, CEO of the Academy for Chief Executives .
**Success Made Simple, Erik Wesner.
See www.advancedclinical.com
Thursday, April 15, 2010
Stay in the loop with Advanced Clinical's Team Integration
Several studies* have been performed on the linkage among team building, team cohesion, and team performance. An integrated team will achieve improvements in performance by developing the right "Team Culture" and adopting the behaviors needed to support and reinforce that culture. A strong Team Culture leads to reduction of waste, duplication, unnecessary processes and procedures. Most importantly, it leads to the willingness to succeed.
Many times there is limited or no effort taken to create a joint view of the goals that should be achieved, build trust among team members, and to integrate the team. As a result, the team is not productive as a unit as they become "disengaged". Disengaged employees are 33% less productive on average according several reports*. This costs companies a lot of money, risk, and time.
To keep clinicians and consultants in the loop, Advanced Clinical has built our "Team Integration Method". Our method succeeds in creating a completely harmonized team, whether working on-site or off-site to ensure maximum employee engagement, productivity and overall performance.
Advanced Clinical believes our consultants should be "close" with not only their colleagues on a project, but the project managers and the client's team as well. Bonding exercises and introductions take place before our clinical trials. Mutual respect and complete communication is ongoing to keep workplace karma good, and, ultimately, to ensure successful trials completion.
We've launched our “Design Your Dream Job” contest to identify the best ways to make employees happy and productive in the workplace. You could win a $200 gift card to any store of your choosing, an iPod shuffle, and maybe the job of your dreams.
Enter today.
*Sources:
Bloom, G. A., Stevens, D. E., and Wickwire, T. L. (2003). Expert coaches’ perceptions of team building. Journal of Applied Sport Psychology. 15: 129-143.
Crron, A.V., Brawley, L.R., and Widmeyer, W. N. (1985). The Group Environment Questionnaire.
Carron, A.V., Bray, S.R., and Eys, M.A. (2002).Team cohesion and team success in sport. Journal of Sports Sciences, 20, 119-126.
Dirks, K.T. (2000). Trust in leadership and team performance: evidence from NCAA basketball. Journal of Applied Psychology, 85(6) 1004-1012.
Ebbeck, V. and Gibbons, S. L. (1998). The effect of a team building program on the self-conceptions of grade 6 and 7 physical education students. Journal of Sport and Exercise Psychology, 20; 300-310.
Everett, J. J., Smith, R. E., and Williams, K.D. (1992). Effects of team cohesion and identifiably on social loafing in relay swimming performance. International Journal of Sport Psychology. 23: 311-324.
Kozub, S.A. & Button, C.J. (2000). The influence of a competitive outcome on perceptions of cohesion in rugby and swimming teams. International Journal of Sport Psychology. 31: 82-95.
Landers, D. M. and Luschen, G. (1974). Team performance outcomes and the cohesiveness of competitive coacting groups. International Review of Sports Sociology. 5: 57-69.
Martin, R. and Davids, K. (1995). The effects of group development techniques on a professional athletic team. The Journal of Social Psychology, 135 (4) 533-535.
Meyer, B.B., Wenger, M.S. (1998). Athletes and adventure education: An Empirical Investigation. International Journal of Sport Psychology, 29, 243-266.
Murphy, J. M. (2001). The effect of a one-time team building exercise on team cohesion.
Sencecal, J., Loughead, T.M., and Bloom (2008). A season-long team-building intervention: examining the effect of team goal setting on cohesion. Journal of Sport & Exercise Psychology, 30, 186-199.
See www.advancedclinical.com
Many times there is limited or no effort taken to create a joint view of the goals that should be achieved, build trust among team members, and to integrate the team. As a result, the team is not productive as a unit as they become "disengaged". Disengaged employees are 33% less productive on average according several reports*. This costs companies a lot of money, risk, and time.
To keep clinicians and consultants in the loop, Advanced Clinical has built our "Team Integration Method". Our method succeeds in creating a completely harmonized team, whether working on-site or off-site to ensure maximum employee engagement, productivity and overall performance.
Advanced Clinical believes our consultants should be "close" with not only their colleagues on a project, but the project managers and the client's team as well. Bonding exercises and introductions take place before our clinical trials. Mutual respect and complete communication is ongoing to keep workplace karma good, and, ultimately, to ensure successful trials completion.
We've launched our “Design Your Dream Job” contest to identify the best ways to make employees happy and productive in the workplace. You could win a $200 gift card to any store of your choosing, an iPod shuffle, and maybe the job of your dreams.
Enter today.
*Sources:
Bloom, G. A., Stevens, D. E., and Wickwire, T. L. (2003). Expert coaches’ perceptions of team building. Journal of Applied Sport Psychology. 15: 129-143.
Crron, A.V., Brawley, L.R., and Widmeyer, W. N. (1985). The Group Environment Questionnaire.
Carron, A.V., Bray, S.R., and Eys, M.A. (2002).Team cohesion and team success in sport. Journal of Sports Sciences, 20, 119-126.
Dirks, K.T. (2000). Trust in leadership and team performance: evidence from NCAA basketball. Journal of Applied Psychology, 85(6) 1004-1012.
Ebbeck, V. and Gibbons, S. L. (1998). The effect of a team building program on the self-conceptions of grade 6 and 7 physical education students. Journal of Sport and Exercise Psychology, 20; 300-310.
Everett, J. J., Smith, R. E., and Williams, K.D. (1992). Effects of team cohesion and identifiably on social loafing in relay swimming performance. International Journal of Sport Psychology. 23: 311-324.
Kozub, S.A. & Button, C.J. (2000). The influence of a competitive outcome on perceptions of cohesion in rugby and swimming teams. International Journal of Sport Psychology. 31: 82-95.
Landers, D. M. and Luschen, G. (1974). Team performance outcomes and the cohesiveness of competitive coacting groups. International Review of Sports Sociology. 5: 57-69.
Martin, R. and Davids, K. (1995). The effects of group development techniques on a professional athletic team. The Journal of Social Psychology, 135 (4) 533-535.
Meyer, B.B., Wenger, M.S. (1998). Athletes and adventure education: An Empirical Investigation. International Journal of Sport Psychology, 29, 243-266.
Murphy, J. M. (2001). The effect of a one-time team building exercise on team cohesion.
Sencecal, J., Loughead, T.M., and Bloom (2008). A season-long team-building intervention: examining the effect of team goal setting on cohesion. Journal of Sport & Exercise Psychology, 30, 186-199.
See www.advancedclinical.com
Friday, April 9, 2010
Design Your Dream Job with Advanced Clinical
We at Advanced Clinical take a tailored approach to designing your dream job. Meet some of our recruiters.
See www.advancedclinical.com
Monday, April 5, 2010
Advanced Clinical launches “Design Your Dream Job” contest
"What's Your Dream Job?"
Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.
World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “Design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.
The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.
You can enter with a description of your dream job, a video, or any other creative form.
Winners will be announced June 20. What's your dream job?
For winners announcement, you can follow Advanced Clinical on facebook or on one of our social networks:
- http://www.facebook.com/pages/Advanced-Clinical-Jobs/312691418900?v=wall&ref=ts
- http://twitter.com/AdvClinicalJobs
- http://youtube.com/AdvancedClinicalJobs
- http://advancedclinicaljobs.blogspot.com/
- http://advancedclinicaljobs.wordpress.com/
See www.advancedclinical.com
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