仕事内容

Kite Pharma is seeking an accomplished and visionary leader to serve as VP and Head of Safety and Pharmacovigilance – Cell Therapy. This executive will set the strategic direction and oversee global safety and pharmacovigilance activities for Kite’s cell therapy portfolio, ensuring scientific excellence, regulatory alignment, and operational rigor. The successful candidate will drive proactive risk management, foster a culture of innovation, and represent Kite in senior leadership and external forums.

Key Responsibilities

Strategic Leadership & Vision

• Develop and execute a global safety and pharmacovigilance strategy aligned with Kite’s corporate objectives and regulatory requirements.

• Serve as the primary safety representative in senior leadership forums, governance bodies, and external engagements with regulatory authorities and partners.

• Champion a culture of safety, scientific integrity, and innovation across the organization.

• Anticipate and shape future strategic initiatives to ensure Kite remains at the forefront of safety science and regulatory compliance.

Team Leadership & Development

• Build, lead, and mentor a high-performing global safety and PV team, fostering a culture of accountability, collaboration, and continuous learning.

• Provide strategic guidance, career development, and performance management for team members, ensuring the team’s growth and success.

• Drive organizational efficiency through effective resource management, outsourcing, and alliances.

Safety Evaluation & Risk Management

• Lead the identification, evaluation, and mitigation of safety risks across the product lifecycle, leveraging advanced analytics and real-world evidence.

• Oversee comprehensive safety signal detection, validation, and management, ensuring timely escalation and resolution of potential safety issues.

• Drive the development and execution of risk management plans, safety specifications, and benefit-risk assessments for regulatory submissions and ongoing clinical programs.

• Provide expert medical oversight for safety data review, including aggregate analyses, periodic safety reports (DSURs, PSURs), and responses to regulatory queries.

• Ensure robust safety surveillance through continuous monitoring of emerging safety data from clinical trials, post-marketing sources, literature, and external databases.

Pharmacovigilance Operations & Compliance

• Oversee global PV systems and processes, including case processing, signal detection, aggregate reporting, and benefit-risk assessments, ensuring compliance with international regulations (FDA, EMA, PMDA, etc.).

• Lead safety-related elements of inspection readiness and manage responses to audits, regulatory inquiries, and corrective action plans.

• Maintain SOPs, safety governance frameworks, and CAPA programs to ensure operational excellence and regulatory compliance.

• Stay abreast of evolving global safety regulations, guidelines, and best practices, proactively updating Kite’s policies and procedures.

Cross-Functional & External Collaboration

• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Manufacturing, and Quality to ensure integrated safety oversight and seamless execution of safety strategies.

• Collaborate with external partners, CROs, and affiliates as needed to ensure consistent safety practices, reporting, and compliance across all programs.

• Represent Kite at external meetings with regulatory authorities, partners, and clinical investigators, advocating for patient safety and Kite’s scientific leadership.

Innovation and Research

• Support and initiate research aimed at advancing safety methodologies and improving patient outcomes in cell therapy.

• Promote the adoption of innovative technologies, data analytics, and digital solutions to enhance safety evaluation and decision-making.

Qualifications

• Advanced degree in medicine, pharmacy, or life sciences (MD, PharmD, PhD preferred).

• 10+ years of experience in pharmacovigilance, drug safety, or related regulatory roles in the biopharmaceutical industry, with significant leadership experience.

• Proven track record in global safety strategy, PV operations, and regulatory engagement, ideally within cell/gene therapy or advanced modalities.

• Understanding of cell therapy modalities, associated safety challenges, and the clinical development process.

• Expertise in safety signal detection, risk management, and benefit-risk assessment, including interactions with regulatory authorities.

• Strong analytical, strategic thinking, and communication skills; ability to influence at all levels of the organization.

• Demonstrated ability to lead cross-functional teams and drive organizational performance.

• Experience with safety databases (e.g., ARGUS, ARISg), and familiarity with global safety regulations (FDA, EMA, ICH, EU GVP, etc.).

Compensation

Kite Therapeutics offers a competitive compensation package commensurate with this senior leadership role.

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.