Associate Director, Medical Affairs - Hepatitis

Job Description
Specific Responsibilities: • Support the development of clinical data through Gilead-sponsored, investigator-sponsored and collaborative studies
Essential Duties and Job Functions: This position will be in the expanding Hepatitis group within Medical Affairs. 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.

• Support the development of clinical data through Gilead-sponsored, 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 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 expertise into study concepts; participate in building study synopsis, 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
• Produce and review abstracts and manuscripts for Gilead-sponsored, investigator-sponsored and collaborative studies; collate Gilead Sciences review comments and share with external author(s) and internal review committees
• Produce 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
• Prepare presentation materials and present scientific data at Internal and External Meetings involving Medical Affairs (e.g., including at Advisory Boards and Investigator Meetings)
• Provide medical and scientific 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 for internal and external scientific meetings involving Medical Affairs
• Other activities, as assigned, to support HBV Medical Affairs
Knowledge, Experience and Skills: • M.D., D.O., PhD (biological or pharmaceutical sciences) or PharmD; > 3 years Industry experience in Medical Affairs, Clinical Development, or Research; clinical trials management, scientific expertise desirable
• Experience in hepatology, infectious diseases, virology or clinical virology highly desirable.
• 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

Company

Gilead

Job Code

State or Province

California

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