VP and Head of Safety and Pharmacovigilance – Cell Therapy
Gilead Sciences, Inc.
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.
**Job Description**
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.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.
While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
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