Director, Patient Safety (MD)

Gilead Sciences•Parsippany, NJ

About The Position

Kite is seeking a highly experienced, strategic Patient Safety Physician (MD) to lead safety activities for CAR-T clinical development programs. The role shapes the safety profile of innovative cell therapies and ensures patient safety, regulatory compliance, and scientific excellence across the product lifecycle. The Medical Director is the lead safety physician for safety-related and benefit-risk decision-making for assigned products, owning and planning product safety strategy and activities. The position is accountable for product safety profiles, patient risk management strategies, and effective safety communications. The successful candidate brings experience managing medical safety activities for products in development and post-marketing and influencing cross-functional teams, including Clinical Development, Regulatory, Biometrics, Medical Affairs, pharmacovigilance/business partners, and affiliates. The role represents Drug Safety on development and product teams, contributes to safety strategy and regulatory interactions, and leads safety review activities. As a people leader, the role is also responsible for fostering inclusion, developing talent, and empowering teams.

Requirements

MD or equivalent.
At least 4 years of experience in drug safety/pharmacovigilance, focused on clinical trials and cross-functional collaboration.
Demonstrated experience as a product safety physician and managing medical safety activities for products in development and post-marketing.
Ability to engage and influence cross-functional teams.

Nice To Haves

Completion of a residency or subspecialty fellowship.
Clinical experience in oncology, rheumatology, and/or neurology.
At least 5 years of experience in drug safety/pharmacovigilance, focused on clinical trials and cross-functional collaboration.
Experience with cell or gene therapy, other immunotherapies such as T-cell engagers or checkpoint inhibitors, and/or inflammation therapies.
Experience working in matrixed environments.
Strong knowledge of global regulatory requirements, including FDA, EMA, and ICH requirements.
Proficiency with safety databases such as ARISg and Argus and signal detection tools such as Empirica and Spotfire.
Exceptional communication, collaboration, and project management skills.
High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.

Responsibilities

Lead ongoing safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.
Author safety sections of protocols, Investigator’s Brochures, clinical study reports (CSRs), DSURs, risk management plans (RMPs), and regulatory documents and 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 analysis and presentation of safety findings.
Present strategic safety insights at internal governance forums, including the Global Safety Leadership Committee (GSLC) and SRC.
Collaborate with Clinical Research, Regulatory, Biostatistics, 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 safety monitoring standards and tools.
Mentor junior safety scientists and contribute to internal training and capability-building initiatives.
Support inspection readiness and successful global regulatory submissions.
Lead strategic planning for safety operations, including SOP updates, audits, and business continuity.
Create inclusion by modeling inclusive leadership and embedding the value of diverse teams in management.
Develop talent by coaching employees on current performance and future potential and supporting their growth.
Empower teams by aligning goals with organizational objectives, holding teams accountable, removing barriers, and connecting them to the broader organization.