Job Description
Kite 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 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.
Qualifications
- MD required; completion of residency or subspecialty fellowship preferred.
- Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.
- Minimum 5+ 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.
- 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.
People Leader Accountabilities
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
