Director, Medical Review (MR)

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s 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 we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

You will manage and oversee the medical review of individual case safety reports (ICSRs) and line listings, for marketed and investigational products, providing medical safety assessment and pharmacovigilance comment. You will also manage audits and peer retrospective medical review quality control (MRQC) activities.

EXAMPLE RESPONSIBILITIES:

• Establishes recognition as an expert on medical safety assessment of individual cases and line listings.

• Performs peer retrospective quality control (QC) of adverse event reports from a medical review perspective.

• Participates in both internal and external educational initiatives.

• Initiates, leads, or contributes to a functional or cross-functional project.

• Participates in process improvement initiatives by identifying areas for improvement and presents solutions.

• Collaborates with global safety leads (GSLs) and global safety strategy leads (GSSLs) on select cases with suspected unexpected serious adverse reactions (SUSARs) from clinical trials.

• May serve on higher level intradepartmental and interdepartmental cross-functional projects.

• May lead or contribute to develop and maintain procedural document and provide training.

• Supports internal and external audit and inspection.

• Provides medical consultation to Patient Safety (PS) Strategic Operations group including Literature Management, Coding Strategy, and Autolabeling Management on an ad hoc basis.

• Provides mentorship and trains junior staff, new hires, and contractors to independently review adverse event reports for investigational and marketed products.

• Responds to medical review-related questions from other functions in a timely manner.

• Makes contributions to process improvement within PS, particularly with adverse event processing and operational aspects of medical review.

• May recruit, hire, mentor, and manage direct reports, with responsibility for team members’ performance evaluations.

• Participates in the biweekly Medical Review team meetings.

• Provides medical input to Strategic Operations on case queries.

• Plays a leadership role by providing medical review support for other functional groups.

• Makes significant contributions to the ongoing development and refinement of medical review processes, standards, practices, efficiencies, and capabilities.

• Directs and oversees development of new procedures and relevant medical review strategies.