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Principal Safety Physician

2 weeks ago

Santa Monica, CA, United States Gilead Sciences Full time

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

We are 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.

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:

  • 5+ years of experience in drug safety/pharmacovigilance, with a focus on clinical trials and cross-functional collaboration.

  • Completion of residency or subspecialty fellowship preferred.

  • Clinical experience in oncology, rheumatology, and/or neurology strongly preferred.

  • 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.

The salary range for this position is:

Bay Area: $243,100.00 - $314,600.00.

Other US Locations: $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 .

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

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.

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.