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Senior Director, Global Safety Physician
Madrigal Pharmaceuticals. Provide medical oversight of assigned investigational and marketed products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical safety oversight, including safety signal evaluation, benefit-risk assessment, and regulatory submissions. Proven ability to lead cross-functional teams and communicate complex safety findings effectively to diverse audiences.
Highest-signal resume keywords
MD Or Equivalent Medical Degree15+ Years Clinical And Pharmaceutical Industry ExperienceExpertise In Safety Signal EvaluationStrong Understanding Of Global Safety RegulationsExperience With Safety Databases Such As Argus And ArisGlobal
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Medical Safety LeadershipBenefit-Risk AssessmentRisk Mitigation StrategiesClinical Development PlansSafety Content ReviewSafety MonitoringCausality AssessmentRegulatory SubmissionsSafety Surveillance MethodologiesPost-Marketing Safety Assessment
Soft Skills
Analytical JudgmentProblem-Solving SkillsExcellent Communication SkillsMentoring And LeadershipInfluencing Cross-Functional Decisions
Tools & Technologies
ArgusArisGlobalMedDRASafety Databases
Certifications & Qualifications
Board-Certification (Preferred)
Industry Keywords
Drug SafetyPharmacovigilanceGCPICH E2 GuidelinesEU GVPFDA RequirementsHealth Authority InteractionsBiotechnologySpecialty Pharmaceuticals
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide medical oversight of assigned investigational and marketed products
- Review and interpret safety data from clinical trials, post-marketing sources, and scientific literature
- Lead evaluation and management of safety signals with safety scientists
- Assess emerging safety findings and recommend risk mitigation and regulatory actions
- Lead medical benefit-risk assessments for assigned products
- Serve as a key member or designated chair of Safety Review Teams and escalate significant issues through governance
- Author or medically review safety content in DSURs, PBRERs, RMPs, IBs, clinical study reports, and regulatory submissions
- Provide medical safety expertise for regulatory filings and health authority interactions
- Contribute to product safety information, labeling, and risk management strategies
- Support inspections and audits as the medical safety subject-matter expert
- Provide 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
- Evaluate emerging safety data to inform clinical development decisions
- Serve as an escalation point for complex or clinically significant safety cases
- Provide expertise to cross-functional governance committees and post-marketing safety activities
- Communicate safety findings, benefit-risk considerations, and recommendations to cross-functional teams and senior leadership
- Identify and escalate significant safety concerns
- Mentor safety physicians and scientific colleagues; manage direct reports where assigned
Requirements
What you’ll need- MD or equivalent medical degree
- 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
- Demonstrated medical safety leadership on clinical development programs, including relevant experience with post-marketing safety assessment
- 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
- Demonstrated ability to work effectively in global, matrixed organizations and influence cross-functional decisions
- Strong clinical reasoning, analytical judgment, and problem-solving skills, including 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
- Specialty training, including board-certification, or relevant clinical experience in therapeutic areas aligned with the company's portfolio (preferred)
- Experience with global regulatory submissions and interactions with FDA, EMA, PMDA, or other major health authorities (preferred)
- Experience chairing or contributing to multidisciplinary safety governance meetings (preferred)
- Experience mentoring safety physicians or scientific colleagues; prior people-management experience is a plus (preferred)
- Experience in a growing biotechnology or specialty pharmaceutical organization (preferred)
Benefits
Comp & perks- Equity for all employees
- Flexible paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- Life and disability insurance
- 401(k) traditional, Roth, and employer match offerings
- Supplemental life insurance
- Legal services
- Mental health benefits through the Employee Assistance Program for employees and their family
- Reasonable accommodations throughout the hiring process