Principal Safety Physician; MD- CAR T Programs
Listed on 2025-11-22
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Healthcare
Principal Safety Physician (MD) – CAR T Programs
Location:
Santa Monica, California (United States).
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. Join Kite and help shape the future of cancer therapies.
Key Responsibilities- Lead ongoing safety signal detection, evaluation, and benefit‑risk assessments across clinical trials and post‑marketing 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.
- MD or equivalent with 4+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross‑functional collaboration.
- 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.
- 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.
The salary range for this position is:
Bay Area: $ – $. Other US Locations: $ – $.
For additional benefits information, visit:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status and other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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