Senior Director, Global Safety Physician

i‑Pharm Consulting; Boston (MA); On-site; USD 230,000 - 320,000; Full time

Job summary

i‑Pharm Consulting seeks a Senior/Executive Director of Global Clinical Safety to provide strategic and medical oversight across clinical development and post-marketing programs.

This highly visible role offers influence over regulatory strategy and global safety governance, with leadership in signal detection, benefit–risk assessment, and safety documentation across the portfolio.

Qualifications

• MD (or equivalent) with advanced training in pharmacovigilance.
• 12–18+ years of clinical safety/pharmacovigilance experience in biotech or pharma.
• Deep expertise in signal detection, safety surveillance, and benefit–risk assessment.
• Experience leading regulatory filings and health authority interactions.

Responsibilities

• Serve as medical and scientific expert for safety across assigned programs (early through late-stage and/or marketed products).
• Lead signal detection, evaluation, and risk management activities, including interpretation of safety data from multiple sources.
• Drive benefit–risk assessments and contribute to safety governance forums (e.g., safety review committees).
• Author and/or review key regulatory safety documents (e.g., DSURs, PBRERs, IBs, safety sections of submissions).
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and PV Operations to align on safety strategy.
• Support global regulatory interactions, including responses to health authority queries.
• Ensure inspection readiness and compliance with global pharmacovigilance regulations (FDA, EMA, ICH, etc.).
• Contribute to the development and scaling of safety processes, infrastructure, and best practices.

Job description

A growing, clinical-stage biopharmaceutical company is seeking a Senior/Executive Director of Global Clinical Safety to play a key leadership role across both clinical development and post-marketing programs. This individual will provide strategic and medical oversight of safety across the portfolio, driving signal detection, benefit–risk assessment, and global safety strategy.

This is a highly visible role within a fast-paced, collaborative environment, with the opportunity to influence regulatory strategy and safety governance at a global level.

Key Responsibilities

• Serve as the medical and scientific expert for safety across assigned programs (early through late-stage and/or marketed products)
• Lead signal detection, evaluation, and risk management activities, including interpretation of safety data from multiple sources
• Drive benefit–risk assessments and contribute to safety governance forums (e.g., safety review committees)
• Author and/or review key regulatory safety documents (e.g., DSURs, PBRERs, IBs, safety sections of submissions)
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and PV Operations to align on safety strategy
• Support global regulatory interactions, including responses to health authority queries
• Ensure inspection readiness and compliance with global pharmacovigilance regulations (FDA, EMA, ICH, etc.)
• Contribute to the development and scaling of safety processes, infrastructure, and best practices

Qualifications

• MD (or equivalent)
• ~12–18+ years of experience in clinical safety/pharmacovigilance within biotech or pharma
• Deep experience across signal detection, safety surveillance, and benefit–risk assessment
• Strong understanding of global safety regulations and reporting requirements
• Proven ability to operate in a matrixed, cross-functional environment
• Prior experience contributing to or leading regulatory filings and health authority interactions
• Demonstrated leadership skills, with experience influencing stakeholders and/or managing teams

Why This Role

• High-impact, strategic leadership position with visibility across the organization
• Opportunity to shape global safety strategy for innovative therapies
• Collaborative, growth-oriented biotech environment with strong pipeline momentum