Director of Medical Governance and Quality

Director, Medical Affairs Research Policy & Governance At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

Join Gilead and help create possible, together.
The Director of Medical Affairs (MA) Policy and Governance 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 implement best practices across TAs; encourage collaboration between MA, Clinical Operations, Health Economics 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 MA in compliance related issues.
Lead development and revision of all MA Research procedures and policies 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 minimize 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 of other related policies and procedures within Development (eg CDS-RWE) for global, and regional teams across all therapeutic areas.
Primary MA contact for cross functional workstreams for compliance-related incidents and audits for MA research studies including deviations, CAPAs, as well as support for robust root cause and impact investigations and resolution.
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.
Minimum of 6-8 years of experience with broad exposure to business functions such as Ethics and Compliance, Legal, Quality.
Demonstrated ability in driving quality process improvement initiatives.
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.
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