Principal Safety Physician; MD- CAR T Programs

Overview

Kite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies, including CAR‑T and TCR engineered cell therapies. We are dedicated to curing cancer by delivering rapid, long‑term durable responses.

• Lead 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 brochures, CSRs, DSURs, RMPs, and regulatory 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 strategic safety insights at governance forums such as the Global Safety Leadership Committee (GSLC) and SRC.
• 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, focused on clinical trials and cross‑functional collaboration.

• 5+ years of experience in drug safety/pharmacovigilance, focused 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.

Bay Area: $ – $
Other US Locations: $ – $

• Discretionary annual bonus and stock‑based long‑term incentives (eligible for role).
• Paid time off.
• Company‑sponsored medical, dental, vision, and life insurance plans.

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants, fostering an inclusive environment. All recruitment and selection decisions will be made without discrimination on any protected characteristic.