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 DescriptionKite is seeking a highly experienced and strategic Patient Safety Physician (MD) to lead safety activities for our CAR-T clinical development programs. This role is pivotal in shaping the safety profile of our innovative cell therapies, ensuring patient safety, regulatory compliance, and scientific excellence across the product lifecycle.The Medical Director will serve as the lead safety physician 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 activities 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 Medical Director 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.Key ResponsibilitiesLead ongoing safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.Serve as the primary author of safety sections in protocols, Investigator’s Brochures, CSRs, DSURs, RMPs, and regulatory documents/responses.Represent Drug Safety on Global Development and Product Teams, providing expert input on safety strategy, protocol design, and regulatory interactions.Prepare and lead Safety Review Committee (SRC) and Data Safety Monitoring Board (DSMB) meetings, including dat...