Principal Safety Physician (MD)- CAR T Programs
About The Position
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 We are 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.
Requirements
- MD or equivalent with 4+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).
- Proficiency in safety databases (e.g., ARISg, Argus) and signal detection tools (e.g., Empirica, Spotfire).
- Exceptional communication, collaboration, and project management skills.
- High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.
Nice To Haves
- 5+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration.
- Completion of residency or subspecialty fellowship preferred.
- Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.
- Experience with Cell or Gene Therapy, other immunotherapies (T-cell Engagers, Checkpoint Inhibitors) and/or Inflammation therapies.
- Proven ability to work in matrixed environments
Responsibilities
- Lead 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 data analysis and presentation of safety findings.
- Present at internal governance forums such as the Global Safety Leadership Committee (GSLC) and SRC, delivering strategic safety insights.
- Collaborate cross-functionally with Clinical Research, Regulatory, Biostats, Medical Affairs, and external partners to align on safety deliverables.
- Ensure data integrity and compliance in safety databases and clinical trial systems.
- 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 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.
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
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
