Director, Patient Safety (MD)

Gilead Sciences; Parsippany-Troy Hills (NJ); On-site; USD 221,000 - 286,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

Kite Pharma seeks an experienced Patient Safety Physician (MD) to lead safety activities for CAR-T programs. You will shape safety strategy, drive risk management, and ensure regulatory compliance across development and post-marketing.

The role requires strong cross-functional collaboration with Clinical Development, Regulatory, and Medical Affairs, plus expertise in safety databases and signal detection. Competitive package offered.

Qualifications

• MD or equivalent with 4+ years of drug safety/pharmacovigilance experience.
• Experience leading safety activities in clinical development and post-marketing.
• Ability to influence cross-functional teams.
• Strong knowledge of global regulatory requirements.
• Proficiency with safety databases (ARISg, Argus) and signal tools.
• Excellent communication and program management skills.
• High attention to detail and scientific rigor.

Responsibilities

• Lead ongoing safety signal detection and benefit-risk assessments across trials and postmarketing.
• Author safety sections in protocols, IBs, CSRs, DSURs, and regulatory responses.
• Represent Drug Safety on Global Development and Product Teams.
• Prepare and lead SRC and DSMB meetings with data analysis and presentations.
• Present safety insights at GSLC and SRC governance forums.
• Collaborate with Clinical Research, Regulatory, Biostats, MA, and external partners.
• Ensure data integrity in safety databases and trial systems.
• Drive safety innovations with real-world evidence and analytics.
• Lead safety operations planning, SOP updates, and audits.
• Mentor junior safety scientists and support training.

Skills

Safety signal detection

Cross-functional collaboration

Regulatory submissions

Data analysis

Communication

Project management

Leadership

Risk management

Education

MD or equivalent

Tools

ARISg

Argus

Empirica

Spotfire

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 fulfill their aspirations. Join Kite and help create more tomorrows.

Job Description

Kite is seeking a highly experienced and strategic Patient Safety Physician (MD) to lead safety activities for our CAR-T clinical development programs. This role is pivotal in shaping the safety profile of our innovative cell therapies, ensuring patient safety, regulatory compliance, and scientific excellence across the product lifecycle.

The Medical Director will serve as the lead safety physician involved in safety related and benefit-risk decision making activities for assigned product(s) at Kite Pharma. The successful candidate will have demonstrated prior career success as a product safety physician and managing the medical safety activities for products in development and post-marketing, as well as effectively engaged and influenced multiple cross functional teams including but not limited to Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, and Affiliates as appropriate.

The Medical Director plays a lead role in owning, shaping and planning the safety strategy and activities for their assigned product(s). This would include acting as the lead point of contact for safety with cross functional leaders, defining safety related objectives, ability to articulate the overall design and the requirement of their defined safety strategy in the context of the overall clinical development program and or post-marketing requirements. This role is accountable for the safety profile, product specific patient risk management strategies and activities and ensure safety communications approaches are implemented and can be demonstrated to be effective.

Key Responsibilities

• Lead ongoing safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.
• Serve as the primary author of safety sections in protocols, Investigator’s Brochures, CSRs, DSURs, RMPs, and regulatory documents/responses.
• Represent Drug Safety on Global Development and Product Teams, providing expert input on safety strategy, protocol design, and regulatory interactions.
• Prepare and lead Safety Review Committee (SRC) and Data Safety Monitoring Board (DSMB) meetings, including data analysis and presentation of safety findings.
• Present at internal governance forums such as the Global Safety Leadership Committee (GSLC) and SRC, delivering strategic safety insights.
• Collaborate cross-functionally with Clinical Research, Regulatory, Biostats, Medical Affairs, and external partners to align on safety deliverables.
• Ensure data integrity and compliance in safety databases and clinical trial systems.
• Drive innovation in safety science, including the use of real-world evidence and advanced analytics.
• Lead process improvements and contribute to the development of safety monitoring standards and tools.
• Mentor junior safety scientists and contribute to internal training and capability-building initiatives.
• Support inspection readiness and contribute to successful global regulatory submissions.
• Lead strategic planning for safety operations, including SOP updates, audits, and business continuity.

Basic Qualifications

• MD or equivalent with 4+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration

Preferred Qualifications:

• MD required; completion of residency or subspecialty fellowship preferred.
• Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.
• Minimum 5+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration.
• Experience with Cell or Gene Therapy, other immunotherapies (T-cell Engagers, Checkpoint Inhibitors) and/or Inflammation therapies.
• Proven ability to work in matrixed environments
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).
• Proficiency in safety databases (e.g., ARISg, Argus) and signal detection tools (e.g., Empirica, Spotfire).
• Exceptional communication, collaboration, and project management skills.
• High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset.

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.

The salary range for this position is: $221,000.00 - $286,000.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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.

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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 [e-mail] for assistance.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.