Director, Patient Safety (MD)

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

Benefits offered by this job

Discretionary annual bonus

Paid time off

Company-sponsored medical, dental, vision, and life insurance

Job summary

Kite Pharma in Parsippany-Troy Hills, NJ is seeking a Medical Director, Patient Safety Physician (MD) to lead safety activities for CAR-T cell therapies. This key role involves shaping the safety profile of innovative cell therapies and ensuring compliance and scientific excellence.

The ideal candidate will possess an MD and at least 5 years of experience in drug safety. They will be responsible for managing safety strategy, collaborating with cross-functional teams, and leading data safety monitoring efforts.

The salary range for this position is $221,000.00 – $286,000.00, with potential for bonuses and a comprehensive benefits package.

Qualifications

• Proven ability to work in matrixed environments.
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH, etc.).
• Experience with Cell or Gene Therapy preferred.

Responsibilities

• Lead ongoing safety signal detection and evaluation.
• Serve as primary author of safety sections in regulatory documents.
• Prepare and lead Safety Review Committee meetings.

Skills

Clinical experience in oncology, rheumatology, and/or neurology

Minimum 5+ years in drug safety/pharmacovigilance

Proficiency in safety databases (e.g., ARISg, Argus)

Exceptional communication skills

High attention to detail

Education

MD required; completion of residency or subspecialty fellowship preferred

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

Job Description

As a Medical Director, Patient Safety Physician (MD), you will 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. You will serve as the lead safety physician, engaging cross‑functional teams such as Clinical Development, Regulatory, Biometrics, Medical Affairs, Pharmacovigilance, Business Partners, and Affiliates. Your responsibilities include owning and defining safety strategy, managing safety communications, and demonstrating effectiveness to senior leadership.

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, Biostatistics, 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.

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.

Compensation & Benefits

Salary range: $221,000.00 – $286,000.00. The position may also be eligible for discretionary annual bonus, discretionary stock‑based long‑term incentives, paid time off, and a benefits package including company‑sponsored medical, dental, vision, and life insurance plans.

Equal Employment Opportunity Statement

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants and is dedicated to fostering an inclusive work environment. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information, gender identity, veteran status, or any other protected characteristic. For assistance with accommodations during the application process, please contact [e-mail].