Head of Safety and Pharmacovigilance – Cell Therapy

Head of Safety and Pharmacovigilance – Cell Therapy Job Description

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. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

• Strategic Leadership
  • Define and execute a comprehensive global safety and pharmacovigilance strategy aligned with corporate objectives and regulatory expectations.
  • Represent the safety function in senior leadership forums, cross-functional governance bodies, and external engagements with regulatory authorities and partners.
  • Champion a culture of safety, scientific integrity, and innovation across the organization.
• Pharmacovigilance Operations
  • Oversee global PV systems and processes, including case processing, signal detection, aggregate reporting, and benefit-risk assessments.
  • Ensure timely and accurate safety data collection, evaluation, and reporting in compliance with international regulations (e.g., FDA, EMA, PMDA).
  • Lead inspection readiness and manage responses to audits and regulatory inquiries.
• Regulatory Compliance and Governance
  • Serve as the primary liaison with global regulatory agencies on safety matters.
  • Ensure compliance with Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), and other applicable standards.
  • Lead the development and maintenance of SOPs, safety governance frameworks, and CAPA programs.
• Risk Management and Safety Science
  • Lead the identification, assessment, and mitigation of safety risks across the product lifecycle.
  • Drive the development of risk management plans and safety specifications for regulatory submissions.
  • Promote the use of advanced analytics and real-world evidence to enhance safety signal detection and decision-making.
• Cross-Functional Collaboration
  • Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and Manufacturing to ensure integrated safety oversight.
  • Collaborate with external partners, CROs, and affiliates to ensure consistent safety practices and reporting.
• Team Leadership and Development
  • Build and lead a high-performing global safety and PV team.
  • Provide mentorship, career development, and performance management for team members.
  • Foster a culture of accountability, collaboration, and continuous learning.
• Innovation and Research
  • Stay abreast of emerging trends in cell therapy, safety science, and regulatory policy.
  • Support research initiatives aimed at improving patient outcomes and advancing safety methodologies.

• Advanced degree in medicine, pharmacy, or life sciences (MD, Pharm
  
  D, PhD preferred).
• 10+ years of experience in pharmacovigilance, drug safety, or related regulatory roles in the biopharmaceutical industry.
• Proven leadership in global safety strategy, PV operations, and regulatory engagement.
• Deep understanding of cell therapy modalities and associated safety challenges.
• Strong analytical, strategic thinking, and communication skills.
• Demonstrated ability to lead cross-functional teams and influence at all levels of the organization.

• 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…