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23 Sep 2011

Director, Medical Affairs – Hepatitis

Gilead Sciences, Inc. – Posted by admin Foster City, California, United States

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases. Gilead’s primary areas of focus include HIV/AIDS, liver disease and serious cardiovascular/metabolic and respiratory conditions. Our portfolio of 13 marketed products includes a number of category firsts and market leaders, including Atripla® (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) – the first single-tablet regimen for HIV infection. Viread® (tenofovir disoproxil fumarate), the company’s first agent approved for HIV infection, was also approved in 2008 for the treatment of chronic hepatitis B. 

Gilead was founded in 1987 in Foster City, California. In just over 20 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 4,000 employees.  In 2009, Gilead’s annual revenues surpassed $7 billion. BusinessWeek ranked Gilead #1 in its 2009 listing of the 50 best-performing companies, up from #2 in 2008.

The following position is available in at our corporate headquarters in Foster City, California:

 

Director, Medical Affairs – Hepatitis

This position will be located in Foster City, CA, reporting to the Senior Director, Hepatitis. The current focus is on chronic hepatitis B and therapeutic opportunities but this position could expand in the future into other areas within hepatology e.g., hepatitis C, non-alcoholic steato-hepatitis.

Job Responsibilities
:

  • Support the development of clinical data through investigator-sponsored and collaborative studies
  • Assist with Gilead-sponsored Phase 4 studies, including medical monitoring duties
  • Support the Hepatitis Phase 4 Study Proposal Committees
  • Assist the Senior Director in all aspects of study management for HBV investigator-sponsored and collaborative trials. Develop and track quarterly and annual reports for the HBV Phase 4 Studies Program
  • Provide scientific input into study proposals; coordinate internal review of proposals, protocols, and other study documents; and liaise with affiliates and investigators
  • Maintain regular contact with investigators to track study progress and publication deliverables; liaise with Scientific Communications colleagues to share information regarding planned publications
  • Review abstracts and manuscripts for investigator-sponsored and collaborative studies; collate Gilead Sciences review comments and share with external author(s) and internal review committees
  • Provide scientific input into manuscripts for publication and presentation at scientific meetings
  • Participate in the HBV Publications Subteam to share information on anticipated publications from Gilead HBV phase 4 studies; maintain study timelines
  • Serve as an information resource to Gilead colleagues, including the Medical Scientists, regarding viral hepatitis and related investigator-sponsored/collaborative studies
  • Present scientific data at Internal and External Meetings involving Medical Affairs (e.g., including at Advisory Boards and Investigator Meetings)
  • Provide medical leadership at key scientific meetings involving viral hepatitis e.g., AASLD, EASL
  • Lead the medical affairs review of promotional material for viral hepatitis (Promotional Review Committee)
  • Lead the medical affairs review of drug safety materials for viral hepatitis
  • Develop effective working relationships with internal and external customers, including Clinical Research, Biometrics, Commercial and Marketing, Contracts/Finance, Virology, Pharmacology, Legal, Medical Scientists and other Gilead Medical Affairs colleagues, Medical Directors/Medical Managers in affiliate offices, investigators, research organizations
  • Develop and review abstracts, manuscripts, posters and slides as requested for internal and external scientific meetings involving Medical Affairs
  • Other activities, as assigned, to support HBV Medical Affairs

 

Knowledge, Experience, and Skills:

M.D. with a medical background in hepatology and/or infectious diseases/virology and 0-5 years Industry experience in Medical Affairs and/or Clinical Research (Clinical Drug Development), including Phase 3 and 4 studies; clinical trials management, medical monitoring and scientific expertise

Experience in hepatology and/or infectious diseases/ clinical virology essential

Experience in clinical patient care role highly desirable

Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings

Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills

Excellent analytical skills, demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications

Excellent teamwork skills

Organized; attention to detail and able to meet timelines in a fast-paced environment

Ability to work on multiple projects simultaneously and effectively prioritize workload

Ability to suggest solutions for issues encountered with clinical studies and other projects in area of responsibility

Must be able to work with a level of autonomy and independence

Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials

 

How to Apply

If you are interested in learning more about this position, or to apply, please visit our website: Gilead Gilead is an equal opportunity employer.

Job Categories: Featured and Non-Clinical. Job Tags: california medical affairs director, gilead sciences director, gilead sciences hepatitis, gilead sciences medical affairs, and hepatitis medical affairs director.

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