Senior Director, Patient Safety – MD

Gilead Sciences

Senior Director Patient Safety leading safety strategies for cancer therapies at Kite Pharma. Collaborating across teams to ensure effective safety measures and communications.

Posted 7/28/2026full-timeFoster City • California, New Jersey • 🇺🇸 United StatesSenior💰 $255,425 - $363,660 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in safety strategy leadership, benefit-risk management, and regulatory compliance in drug safety and pharmacovigilance. Proven ability to analyze safety data, mentor teams, and drive innovation in safety science.

Highest-signal resume keywords

MD Required10+ Years Experience in Drug Safety/PharmacovigilanceAdvanced Knowledge of Global Regulatory RequirementsExpertise in Safety Signal Detection MethodologiesProficiency in Safety Databases

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Experience in OncologyClinical Experience in RheumatologyClinical Experience in NeurologyBenefit-Risk AssessmentAggregate Safety Data AnalysisRegulatory Safety Document AuthoringPharmacoepidemiology ConceptsSignal Detection MethodologiesSafety Monitoring MeasuresReal-World Evidence Analysis

Soft Skills

Excellent Interpersonal SkillsStrong Written Communication SkillsStrong Oral Communication SkillsHigh Attention to DetailProactive Mindset

Tools & Technologies

ArgusEmpiricaSpotfire

Industry Keywords

Drug SafetyPharmacovigilanceCell TherapyGene TherapyImmunotherapiesT-Cell EngagersCheckpoint InhibitorsInflammation TherapiesFDA RegulationsEMA Regulations

About the role

Key responsibilities & impact

Serve as the safety strategy leader involved in safety related and benefit-risk decision making activities for assigned product(s) at Kite Pharma
Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as relevant strategic context (e.g., safety profile of existing standard of care, treatment landscape)
Recommend appropriate safety monitoring measures for safety issues
Lead safety signal surveillance, and aggregate data analysis for assigned product(s) on an ongoing basis in collaboration with the PV Scientist and/or Clinical Physician/Scientist
Develop the strategy and implementation of safety and benefit-risk management for assigned products
Accountable for content in the aggregate reports (such as DSUR, PADER, PBRER) and Risk Management documents (RMPs) for assigned products
Lead cross-functional product safety committee (PSC) meetings and collaborate with team members to ensure patient safety for assigned products
Support and collaborate with cross-functional teams on safety related activities, preparing and presenting safety data at meetings, providing responses to Health Authority requests, or business development queries
Drive innovation in safety science, including the use of real-world evidence and advanced analytics
Mentor junior safety physicians and scientists and contribute to internal training and capability-building initiatives
Support inspection readiness and contribute to successful global regulatory submissions

Requirements

What you’ll need

MD required; completion of residency or subspecialty fellowship preferred
Clinical experience in oncology, rheumatology, and/or neurology strongly preferred
Minimum 10+ 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 preferred
Advanced knowledge of global regulatory requirements (FDA, EMA, ICH, etc.)
Proven ability to work in matrixed environments
Ability to assess product benefit-risk profiles and interpret clinical and post-market safety data
Demonstrated expertise in safety signal detection methodologies and medical evaluation of aggregate safety databases
Ability to author and critically review regulatory safety documents (DSURs, PBRER safety sections, health authority responses)
Familiarity with pharmacoepidemiology concepts and study design
Proficiency in safety databases (e.g.,Argus) and signal detection tools (e.g., Empirica, Spotfire)
Excellent interpersonal, written, and oral communication skills; ability to effectively communicate complex safety findings to internal and external stakeholders
High attention to detail, scientific rigor, and a proactive, solutions-oriented mindset
Demonstrated ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture

Benefits

Comp & perks

company-sponsored medical, dental, vision, and life insurance plans*
paid time off