Director, Patient Safety (MD)

Gilead Sciences • Parsippany, NJ

5d • $221,000 - $286,000

About The Position

Kite is seeking a highly experienced and strategic Patient Safety Physician (MD) to lead safety activities for its CAR-T clinical development programs. The role shapes the safety profile of innovative cell therapies and helps ensure patient safety, regulatory compliance, and scientific excellence throughout the product lifecycle.

The Medical Director serves as the lead safety physician for safety-related and benefit-risk decision-making for assigned products. The role leads the safety strategy and activities, acts as the main safety contact for cross-functional leaders, defines safety objectives, and explains how the safety strategy supports the broader clinical development program and post-marketing requirements. The role is accountable for product safety profiles, patient risk-management strategies, and effective implementation of safety communications.

The successful candidate has experience as a product safety physician managing medical safety activities for products in development and post-marketing, and can engage and influence cross-functional teams. As a people leader, the role also supports inclusion, employee development, and team empowerment.

Requirements

• MD or equivalent.
• At least 4 years of drug safety or pharmacovigilance experience, focused on clinical trials and cross-functional collaboration.
• Demonstrated experience as a product safety physician 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 drug safety or pharmacovigilance experience, 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.
• Ability to work effectively 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 safety signal detection, evaluation, and benefit-risk assessments across clinical trials and post-marketing settings.
• Author safety sections for protocols, Investigator’s Brochures, clinical study reports, DSURs, RMPs, and regulatory documents and responses.
• Represent Drug Safety on Global Development and Product Teams, advising on safety strategy, protocol design, and regulatory interactions.
• Prepare and lead Safety Review Committee and Data Safety Monitoring Board meetings, including analysis and presentation of safety findings.
• Present strategic safety insights at internal governance forums, including the Global Safety Leadership Committee and Safety Review Committee.
• Collaborate with Clinical Research, Regulatory, Biostatistics, Medical Affairs, and external partners to align safety deliverables.
• Ensure data integrity and compliance in safety databases and clinical trial systems.
• Advance safety science through real-world evidence and advanced analytics.
• Lead process improvements and help develop safety monitoring standards and tools.
• Mentor junior safety scientists and contribute to internal training and capability building.
• Support inspection readiness and successful global regulatory submissions.
• Lead strategic planning for safety operations, including SOP updates, audits, and business continuity.
• Create an inclusive team environment, develop employee talent, and empower teams by aligning goals and removing barriers.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree