Senior Director, Patient Safety (MD)

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

Job Description

The Senior Director Patient Safety (MD) will serve as the safety strategy leader involved in safety related and benefit-risk decision making activities for assigned product(s) at Kite Pharma. The successful candidate will have demonstrated prior career success as a product safety physician and managing the medical safety strategy for products in development and post-marketing, as well as effectively engaged and influenced multiple cross functional teams including but not limited to Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, and Affiliates as appropriate.

The Senior Director Patient Safety (MD) plays a lead role in owning, shaping and planning the safety strategy and activities for their assigned product(s). This would include acting as the lead point of contact for safety with cross functional leaders, defining safety related objectives, ability to articulate the overall design and the requirement of their defined safety strategy in the context of the overall clinical development program and or post-marketing requirements. This role is accountable for the safety profile, product specific patient risk management strategies and activities and ensure safety communications approaches are implemented and can be demonstrated to be effective.

The Senior Director Patient Safety (MD) role is pivotal to the overall success of the product(s) they are assigned to. They are empowered to work independently under the oversight of VP, Head of Global Safety.

Job responsibilities

• The Senior Medical Director is accountable for establishing and maintaining the company position on the safety profile and to shape the risk management strategy and proactive patient risk communication for their assigned product(s).
• They develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as relevant strategic context (e.g., safety profile of existing standard of care, treatment landscape)
• They are responsible for recommending appropriate safety monitoring measures for safety issues.
• They are accountable for signal detection and evaluation, aggregate safety reviews, and preparation of periodic aggregate safety report and the medical review oversight of SUSARs
• Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis in collaboration with the PV Scientist and/or Clinical Physician/Scientist.
• Will develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Accountable for content in the aggregate reports (such as DSUR, PADER, PBRER) and Risk Management documents (RMPs) for assigned products.
• They contribute and provide expert content reviews for safety aspects of their product(s) for protocols, IBs, ICFs safety label updates, Safety management plan(s), Risk Management plan across the life cycle of the product(s) as well as long term follow up studies.
• Lead cross-functional product safety committee (PSC) meetings and collaborate with team members to ensure patient safety for assigned products.
• Support and collaborate with cross-functional teams on safety related activities, preparing and presenting safety data at meetings, providing responses to Health Authority requests, or business development queries.
• Support and contribute to the development of Pharmacovigilance Agreements as needed.
• Provide strategy and input into development of product risk strategy and documents as needed including RMP and REMS.
• Present at internal governance forums such as the Global Safety Leadership Committee (GSLC) and SRC, delivering strategic safety insights.
• Drive innovation in safety science, including the use of real-world evidence and advanced analytics
• Lead process improvements and contribute to the development of safety monitoring standards and tools.
• Mentor junior safety physicians and scientists and contri