Senior Safety Science Manager

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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
 

Safety Science is a core function within Gilead's Patient Safety organization. Safety Science provides critical strategic input into cross-functional drug development planning and execution across the product lifecycle, from discovery to post-marketing.  Safety Science performs continuous and proactive medical surveillance and benefit-risk evaluation for all of Gilead's therapies throughout their lifecycle. Among its many responsibilities, Safety Science provides scientific and medical input on all safety issues, identifies, and manages safety signals using internal and external safety data sources, leads authoring of or makes critical contributions into and reviews aggregate safety reports, prepares or approves Risk Management Plans (RMPs), leads the Gilead Structured Assessment of Benefit-Risk (G.SABeR), and safety-related regulatory responses for all products, compounds and indications across Gilead's therapeutic areas, including key quality checks.  Safety Science also leads relevant PV processes and provides medical monitor support for non-interventional post-marketing studies.

POSITION OVERVIEW:

You will perform core safety science activities, including signal detection, development of benefit-risk evaluation management plans, risk minimization activities, leading the authoring of, or contributing input into aggregate safety reports, providing safety science input into study-related activities and documents and regulatory submissions, and providing the safety science perspective into PV processes, to ensure these are completed in a timely and quality manner, or provide oversight of these tasks if outsourced. You will provide safety science input into clinical trial protocols, develop appropriate regulatory responses, and provide the safety science perspective in PV audits and inspections. You will perform some of these responsibilities with supervision from a more experienced Safety Scientist or Physician. You will help ensure that safety documentation is stored appropriately and provide support for inspections and audits.

EXAMPLE RESPONSIBILITIES:

• Authors or otherwise contributes to the preparation of aggregate safety reports, including DUSRs and PBRERs and G.SABeRs, and RMPs.

• Conducts signal detection and evaluation activities for assigned products in collaboration with the Safety Physician as part of the continuous benefit-risk evaluation throughout the product lifecycle.

• Conducts literature review for assigned molecules.

• Supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables.

• May contribute to Safety Science activities a