Kitepharma

Kitepharma

Director, Patient Safety (MD)

United States - New Jersey - Parsippany · Director

Sponsorship not specified$221k-$286kDetected 6 days ago
Data AnalysisComplianceProduct ManagementProject ManagementClinical TrialsClinical ResearchFDA RegulatoryCRISPRPharmacovigilanceResearchLeadershipCommunicationCollaboration

About the role

  • We're here for one reason and one reason only - to cure cancer.
  • We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm.
  • Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Responsibilities

  • 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.
  • 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.
  • 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.
  • We promote and support individual differences and diversity of thoughts and opinion.

Requirements

  • MD required
  • 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.

Nice to have

  • Present at internal governance forums such as the Global Safety Leadership Committee (GSLC) and SRC, delivering strategic safety insights.
  • Ensure data integrity and compliance in safety databases and clinical trial systems.
  • 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.).

Compensation

  • $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*.
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
  • Lead ongoing safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.
  • Collaborate cross-functionally with Clinical Research, Regulatory, Biostats, Medical Affairs, and external partners to align on safety deliverables.

Company info

  • Every moment is dedicated to developing treatments and every action moves us one step closer to our goal.
  • But we're not finished yet.
  • 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.

Equal opportunity

  • 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.
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This listing is sourced directly from Kitepharma's careers page and normalized into a canonical job model.