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 individual will build and develop processes for the evaluation of pharmacovigilance data, playing a key role in ensuring patient safety through proactive safety surveillance, signal detection, and safety governance processes. The role will collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, and external PV vendors as appropriate to maintain a compliant and efficient safety infrastructure. This role requires deep pharmacovigilance expertise, sound clinical judgment, and an owner mindset to scale PV capabilities in a dynamic, growing biopharma environment.

Responsibilities

• Leads & sets the standard for ongoing surveillance of pharmacovigilance data, including the signal detection process and deliverables, ongoing risk assessment, and benefit-risk evaluations; builds processes, templates and training in support of these activities
• Ensure accurate and up-to-date safety information is contained in key documents such as Company Core Safety Information (CCSI), reference safety information such as 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
• Ensures preparation (e.g. slide presentations) for cross-functional safety governance meetings; may present key data/analyses at these meetings.
• Support epidemiology work needed to assess and categorize risk
• Ensure consistent application of SOPs, regulatory compliance, and audit/inspection readiness

Qualifications

• 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

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

Education

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