Senior Director, Global Safety Physician

Madrigal Pharmaceuticals•Conshohocken, PA

1d•$318,104 - $388,792

About The Position

The Senior Director, Global Safety Physician provides medical safety leadership for assigned investigational and marketed products. The role is accountable for medically sound safety assessments, ongoing benefit-risk evaluation, and timely recommendations to protect patients. It partners closely with safety scientists, Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations, and contributes to regulatory submissions and safety governance. Serving as a medical expert and strategic advisor for assigned programs, the Senior Director leads medical safety strategy, reviews critical safety documents, supports health authority interactions, escalates significant risks, and mentors colleagues as appropriate. The position combines clinical judgment, scientific rigor, and collaborative leadership to make independent, well-supported safety recommendations.

Requirements

MD or equivalent medical degree and completion of relevant clinical training.
Approximately 15 or more years of relevant combined clinical and pharmaceutical industry experience, including meaningful experience in drug safety or pharmacovigilance.
Substantial experience in clinical safety, pharmacovigilance, or pharmaceutical clinical development.
Demonstrated medical safety leadership on clinical development programs, including relevant post-marketing safety assessment experience.
Strong understanding of global safety regulations and guidelines, including GCP, ICH E2 guidelines, EU GVP, and FDA requirements.
Expertise in safety signal evaluation, medical causality assessment, benefit-risk assessment, and risk mitigation.
Experience preparing or medically reviewing safety content for regulatory submissions and participating in safety governance and health authority interactions.
Working knowledge of safety databases such as Argus and ArisGlobal, MedDRA, and safety surveillance methodologies.
Ability to work effectively in global, matrixed organizations and influence cross-functional decisions.
Strong clinical reasoning, analytical judgment, and problem-solving skills, including making timely recommendations when evidence is incomplete or conflicting.
Excellent written and verbal communication skills, including the ability to present complex medical and scientific information clearly to diverse audiences.

Nice To Haves

Specialty training, including board-certification, or relevant clinical experience in therapeutic areas aligned with the company's portfolio.
Experience with global regulatory submissions and interactions with FDA, EMA, PMDA, or other major health authorities.
Experience chairing or contributing to multidisciplinary safety governance meetings.
Experience mentoring safety physicians or scientific colleagues; prior people-management experience is a plus.
Experience in a growing biotechnology or specialty pharmaceutical organization.

Responsibilities

Provide medical oversight of assigned products by reviewing and interpreting safety data from clinical trials, post-marketing sources, and scientific literature.
Lead medical evaluation and management of safety signals in partnership with safety scientists responsible for routine surveillance and process execution.
Assess emerging safety findings, determine their medical significance, and recommend appropriate risk mitigation and regulatory actions.
Lead medical benefit-risk assessments, integrating clinical, nonclinical, and post-marketing evidence to inform development and lifecycle decisions.
Serve as a key member or designated chair of Safety Review Teams, present evidence-based recommendations, and escalate significant issues through established governance.
Author or medically review safety content in regulatory documents, including DSURs, PBRERs, RMPs, IBs, clinical study reports, and regulatory submissions.
Provide medical safety expertise for regulatory filings and interactions, including INDs, NDAs/BLAs, marketing authorization applications, and responses to health authority inquiries.
Contribute to product safety information, labeling, and risk management strategies throughout the product lifecycle.
Support inspections and audits as the medical safety subject-matter expert, ensuring assessments, decisions, and supporting documentation are scientifically defensible and inspection-ready.
Maintain awareness of emerging scientific evidence, therapeutic developments, and regulatory expectations relevant to assigned products.
Provide proactive medical safety input into clinical development plans, study protocols, safety monitoring, stopping rules, and risk mitigation strategies.
Develop and execute medical safety strategy for assigned products and studies in partnership with Clinical Development, Biostatistics, Regulatory Affairs, and other stakeholders.
Evaluate emerging safety data to inform clinical development decisions and recommend changes to monitoring or risk management as appropriate.
Serve as an escalation point for complex or clinically significant safety cases from internal and external medical review teams, collaborating with PV Operations and safety scientists on consistent evaluations.
Provide medical safety expertise to cross-functional governance committees and collaborate with Medical Affairs on relevant post-marketing safety activities.
Communicate safety findings, benefit-risk considerations, and actionable recommendations to cross-functional teams, safety governance forums, and senior leadership.
Exercise independent medical judgment, constructively challenge assumptions, and influence decisions through balanced scientific reasoning.
Identify and promptly escalate significant safety concerns with clear, actionable recommendations.
Foster collaboration, scientific rigor, accountability, and continuous improvement across safety activities.
Mentor safety physicians and scientific colleagues, and manage direct reports where assigned.

Benefits

Equity for all employees.
Flexible paid time off.
Medical insurance.
Dental insurance.
Vision insurance.
Life and disability insurance.
401(k) offerings, including traditional, Roth, and employer match.
Voluntary supplemental life insurance.
Legal services.
Mental health benefits through the Employee Assistance Program for employees and their family.
Other benefits in accordance with applicable federal, state, and local laws.