Showing posts with label CRO. Show all posts
Showing posts with label CRO. Show all posts

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, June 3, 2010

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