Senior Director, Patient Safety (MD)

About the role

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.

Job Responsibilities

• Serve as the safety strategy leader involved in safety related and benefit-risk decision making activities for assigned product(s) at Kite Pharma.
• Manage the medical safety strategy for products in development and post-marketing, and effectively engage and influence multiple cross-functional teams including Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, and Affiliates as appropriate.
• Define safety related objectives, articulate the overall design and the requirement of your defined safety strategy in the context of the overall clinical development program and or post-marketing requirements.
• Ensure the safety profile, product specific patient risk management strategies and activities are implemented and demonstrate effectiveness through safety communications.
• Lead safety signal surveillance, aggregate data analysis for assigned product(s) on an ongoing basis in collaboration with the PV Scientist and/or Clinical Physician/Scientist.
• Develop the strategy and implementation of safety and benefit-risk management for assigned products, contributing to and providing expert content reviews for safety aspects of their product(s).
• 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.
• 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.
• 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 contribute to internal training and capability-building initiatives.
• Support inspection readiness and contribute to successful global regulatory submissions.
• Lead strategic planning for safety operations, including SOP updates, audits, and business continuity.

Basic Qualification

• MD required; completion of residency or subspecialty fellowship preferred.
• Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.
• Minimum 10+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration.
• Experience with Cell or Gene Therapy, other immunotherapies (T-cell Engagers, Checkpoint Inhibitors) and/or Inflammation therapies preferred.
• Proven ability to work in matrixed environments.
• Advanced knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).
• Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases.
• Profound ability to assess product benefit-risk profiles and interpret clinical and post-market safety data.
• Familiarity with pharmacoepidemiology concepts and study design.
• Proficiency in safety databases (e.g., Argus) and signal detection tools (e.g., Empirica, Spotfire).
• Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders.
• High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.
• Demonstrated ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture.

Potential Pay Range

The salary range for this position is: Bay Area: $281,010.00 - $363,660.00. Other US Locations: $255,425.00 - $330,550.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing.