Head of Safety and Pharmacovigilance Cell Therapy

Head Of Safety And Pharmacovigilance Cell Therapy

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.

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The Head Of Safety And Pharmacovigilance Cell Therapy leads a specialized and expanding global team of scientists and clinicians dedicated to advancing safety across the cell therapy portfolio. This executive role is responsible for setting the strategic direction, governance, and operational execution of safety and pharmacovigilance activities for both investigational and marketed products.

Reporting to the SVP, Development, the Head Of Safety And Pharmacovigilance is a key member of the Development Leadership Team and participates in cross-functional and executive-level forums. This leader ensures global regulatory alignment, scientific excellence, and operational rigor in all safety-related activities, while fostering a culture of proactive risk management, compliance, and continuous improvement.

Key Responsibilities

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.

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.

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.

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 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.

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.