Senior Director, Patient Safety – MD

• 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

• 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

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.

• MD Required
• 10+ Years Experience in Drug Safety/Pharmacovigilance
• Expertise in Safety Signal Detection Methodologies
• Advanced Knowledge of Global Regulatory Requirements
• Proficiency in Safety Databases (e.g., Argus)

• Clinical Experience in Oncology
• Clinical Experience in Rheumatology
• Clinical Experience in Neurology
• Ability to Assess Product Benefit-Risk Profiles
• Ability to Author Regulatory Safety Documents
• Familiarity with Pharmacoepidemiology Concepts
• Expertise in Medical Evaluation of Aggregate Safety Databases
• Experience with Cell or Gene Therapy
• Experience with Immunotherapies
• Attention to Detail

• Excellent Interpersonal Skills
• Strong Written Communication Skills
• Strong Oral Communication Skills
• Proactive Mindset
• Ability to Collaborate in Matrixed Environments

• Completion of Residency or Subspecialty Fellowship Preferred

• Drug Safety
• Pharmacovigilance
• Clinical Trials
• Cross-Functional Collaboration
• Risk Management
• Safety Communications
• Aggregate Reports (DSUR, PBRER)
• Regulatory Requirements (FDA, EMA, ICH)
• Patient Risk Management Strategies
• Safety Profile

• Safety Databases
• Signal Detection Tools (e.g., Empirica, Spotfire)