Senior Director, Drug Safety

Senior Director, Drug Safety

Direct Hire Full-Time Role

Salary Range: $250,000 - $270,000 per year

Location: Palo Alto, CA - Hybrid Role

Job Summary:

The Senior Director, Drug Safety, will be responsible for the operational oversight of global drug safety activities across both clinical development and eventually post-marketing.

Duties and Responsibilities:

• Lead safety monitoring for investigational and marketed products, ensuring alignment with corporate development strategies.
• Oversee core safety deliverables, including safety governance, signal detection/management, periodic/aggregate reporting, and case processing.
• Supervise and mentor all safety scientists, fostering a collaborative and high-performing team.
• Conduct safety analyses using case series, data summaries, adverse event trends, and clinical/post-marketing data.
• Review medical and scientific literature for signal detection and aggregate reporting.
• Develop and maintain product-specific Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• Perform safety data monitoring, interpretation, and analysis.
• Lead the preparation of safety deliverables, including integrated safety reports and regulatory documents (e.g., PBRER/PSUR, DSUR, PADERs).
• Provide safety input to clinical documents such as Investigator's Brochures, study protocols, and clinical study reports.
• Ensure consistency in safety and risk management content across regulatory submissions.
• Partner with safety physicians and cross-functional teams on signal detection and risk management activities.
• Participate in safety governance meetings and contribute to benefit-risk assessments.
• Author and review safety sections for regulatory packages, including NDAs and responses to health authority queries.
• Support pharmacovigilance process improvement initiatives and inspections/audits.
• Maintain up-to-date expertise in disease areas, drug safety, regulatory trends, and business practices.

Requirements and Qualifications:

• Advanced Degrees (e.g., Master's, PharmD, RN, MD) preferred.
• Extensive experience in pharmacovigilance across late-stage clinical development stages
• Global experience and deep understanding of regulatory requirements across major markets (FDA, EMA, etc.)
• Demonstrated experience authoring and reviewing key regulatory and safety documents
• Hands-on leadership style with experience in small to mid-sized biotech environments
• Strong cross-functional collaboration and communication skills

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