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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 Kites 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.
Develop and execute a global safety and pharmacovigilance strategy aligned with Kites 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.
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 teams growth and success.
Drive organizational efficiency through effective resource management outsourcing and alliances.
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.
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 Kites policies and procedures.
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 Kites scientific leadership.
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.
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.).
Kite Therapeutics offers a competitive compensation package commensurate with this senior leadership role.
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 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 disabilitygenetic 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 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 for assistance. For more information about equal employment opportunity protections please view theKnow Your Rights poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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. Please apply via the Internal Career Opportunities portal in Workday.
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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
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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:
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Kite is dedicated to curing cancer. Learn about the science of cell therapy, our cancer research, and our cancer treatments in the pipeline.