Senior Director, Safety Surveillance

Role Summary

The Senior Director Safety Surveillance is a key leader responsible for providing strategic oversight and operational leadership of pharmacovigilance activities across Madrigal’s clinical development and marketed programs. This role builds and develops processes for the evaluation of pharmacovigilance data to ensure patient safety through proactive safety surveillance, signal detection, and safety governance. The role collaborates with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, and external PV vendors to maintain a compliant and efficient safety infrastructure. Requires deep pharmacovigilance expertise, sound clinical judgment, and the ability to scale PV capabilities in a dynamic biopharma environment.

Responsibilities

• Leads and sets the standard for ongoing surveillance of pharmacovigilance data, including signal detection, risk assessment, and benefit-risk evaluations; builds processes, templates, and training
• Ensure accurate and up-to-date safety information in key documents such as Company Core Safety Information (CCSI), reference safety information, local and regional labels, and Investigator Brochures
• In collaboration with the PV medical team, author safety topic assessment reports in response to potential safety signals or Health Authority queries
• Prepare (e.g., slide presentations) for cross-functional safety governance meetings; may present key data/analyses
• Support epidemiology work needed to assess and categorize risk
• Ensure consistent application of SOPs, regulatory compliance, and audit/inspection readiness

Specialized Knowledge & Skills

• Proven ability to build and lead safety sciences function, including experience hiring and managing direct reports
• Deep understanding of pharmacovigilance principles and regulatory frameworks across global markets
• Strong scientific and clinical acumen, with the ability to synthesize safety data and communicate risk clearly; excellent presentation skills
• Skilled at building relationships and influencing across matrixed environments
• Excellent organizational skills with high attention to detail and operational rigor, with comfort managing ambiguity and evolving infrastructure
• Highly experienced in mentoring, developing, and scaling pharmacovigilance teams and processes

Educational Requirements

• Advanced degree preferred: PharmD, PhD, NP/PA

Experience

• Minimum 15+ years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry
• Minimum of 5+ years of direct and indirect people management experience