Director, Medical Affairs Research

Job Description

The Director of Medical Affairs Research (MAR) is responsible for developing, revising, and implementing the research procedural frameworks and cross-functional support for global and local MA research across all therapeutic areas as well as MA-funded externally sponsored research (ie independent Investigator Sponsored Research and collaborative research. The position will work collaboratively with other functions to ensure consistency and synergies in procedures and responsibilities related to all aspects of late phase research within MA and across Development and HEOR. In addition, the incumbent will be responsible for training on MA-related research activities by the global and local functions as well as representing MAR in compliance related issues.

Essential Duties and Job Functions:

• Lead development and revision of all MA Research procedural documents ensuring the procedural framework is updated promptly to reflect changes in scope and responsibilities.

• Continuously evaluate and improve internal MA research processes to ensure efficiency and effectiveness in supporting MA-led Gilead sponsored and externally sponsored research.

• Lead a forum for Research Committee members to identify and minimizes unnecessary bureaucracy and optimize research-related workflows resulting in high quality proposals and standardization and improvements in proposal reviews

• Develop, deliver and update a comprehensive training program on MA research policies and procedures including other relevant functional policies and procedures where necessary to global and local research committee chairs, committee members and reviewers, MA study Leads, Global Project Managers, and Regional Representatives

• Operationalize MA Research processes among MA internal stakeholders and cross functional partners, including ongoing training and educational sessions to enhance compliance in the execution of MA research

• Act as a trusted technical subject matter expert and key point of contact for all matters governed by Global and Local MA Research policies and procedures with a robust understanding other related policies and procedures within Development (eg CDS-RWE) for global, and regional teams across all therapeutic area.

• Primary MAR contact for cross functional workstreams for compliance-related incidence and audits for MA research studies including deviations, CAPAs, as well as support for robust root cause and impact investigations and resolution.

Knowledge, Experience and Skills:

• BS/BA required. Advanced degree strongly preferred (e.g. MPH, PhD, PharmD in life sciences: biological, pharmaceutical sciences, epidemiology, or similar)

• Proven track record managing or contributing to the execution of interventional phase 3 and phase 4, industry sponsored research and/or observational research across the lifecycle. Experience in academic clinical research preferable

• Strong knowledge of GXP/ICH/FDA/EU requirements.

• Minimum of 6-8 years of experience with broad exposure to business functions such as Ethics and Compliance, Legal, Quality

• Must have strong attention to detail, excellent written and verbal skills

• Aptitude to effectively influence, direct, and collaborate with internal and external team members at all levels without defined authority as well as the ability to work successfully in cross functional teams

• Demonstrated ability in driving quality process improvement initiatives

• Demonstrated ability to analyze complex issues, develop effective strategies, and make sound recommendations or decisions.

• The ability to multitask on a number of projects with tight timelines while maintaining excellent attention to detail is required

• Thorough knowledge and experience with Microsoft Office suite

• Ability to travel as dictated by business needs