Senior Director, Patient Safety – MD

Gilead Sciences

Senior Director Patient Safety at Kite Pharma overseeing safety strategies and benefit-risk decision making for innovative cancer treatments. Collaborating across functions to ensure effective safety management and communication.

Posted 7/27/2026full-timeFoster City • California, New Jersey • 🇺🇸 United StatesSenior💰 $255,425 - $363,660 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in product safety strategy, including risk management and safety communications, with a strong focus on clinical trials and cross-functional collaboration. Proficient in regulatory safety document authoring and safety signal detection methodologies.

Highest-signal resume keywords

MD Required10+ Years Experience in Drug Safety/PharmacovigilanceExpertise in Safety Signal Detection MethodologiesAdvanced Knowledge of Global Regulatory RequirementsProficiency in Safety Databases (e.g., Argus)

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 NeurologyAbility to Assess Product Benefit-Risk ProfilesAbility to Author Regulatory Safety DocumentsFamiliarity with Pharmacoepidemiology ConceptsExpertise in Medical Evaluation of Aggregate Safety DatabasesExperience with Cell or Gene TherapyExperience with ImmunotherapiesAttention to Detail

Soft Skills

Excellent Interpersonal SkillsStrong Written Communication SkillsStrong Oral Communication SkillsProactive MindsetAbility to Collaborate in Matrixed Environments

Tools & Technologies

Safety DatabasesSignal Detection Tools (e.g., Empirica, Spotfire)

Certifications & Qualifications

Completion of Residency or Subspecialty Fellowship Preferred

Industry Keywords

Drug SafetyPharmacovigilanceClinical TrialsCross-Functional CollaborationRisk ManagementSafety CommunicationsAggregate Reports (DSUR, PBRER)Regulatory Requirements (FDA, EMA, ICH)Patient Risk Management StrategiesSafety Profile

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)
demonstrate prior career success as a product safety physician and managing the medical safety strategy for products in development and post-marketing
effectively engage and influence multiple cross functional teams including but not limited to Clinical Development, Regulatory, Biometrics, Medical Affairs, PV/Business partners, and Affiliates as appropriate
lead contact for safety with cross functional leaders, defining safety related objectives
articulate the overall design and requirement of defined safety strategy in the context of overall clinical development program and post-marketing requirements
accountable for safety profile, product specific patient risk management strategies and activities
implement safety communications approaches and ensure effectiveness
accountable for content in aggregate reports (such as DSUR, PADER, PBRER) and Risk Management documents (RMPs) for assigned products
contribute and provide expert content reviews for safety aspects of protocols, IBs, ICFs safety label updates, Risk Management plan across product life cycle
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

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
proven ability to work in matrixed environments
advanced knowledge of global regulatory requirements (FDA, EMA, ICH, etc.)
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
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off