Senior Director, Global Safety Physician
Madrigal Pharmaceuticals - Conshohocken, PA
Hiring: Senior Director, Global Safety Physician Company: Madrigal Pharmaceuticals Location: Conshohocken, PA Job Posted Time: 2026-09-10 14:13:48 Employment Type: Full-time Target Skills & Keywords : GCP About the job Experience: •15+ years of combined, relevant experience in industry, clinical safety, pharmacovigilance, or related roles within biotech / pharma •All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Required Skills: •The Senior Director will serve as a medical expert for safety matters, supporting both investigational and marketed products. Additionally, the role will lead clinical safety strategy, author and review safety-related documents and responses to health authority queries, and support regulatory interactions. •Medical Oversight & Signal Management •Provide medical oversight for clinical safety signals, including review and interpretation of safety data from clinical trials, spontaneous reports, and literature. •Lead or participate in safety signal detection, evaluation, validation, and documentation in collaboration with safety scientists and other stakeholders. •Serve as a key member or chair of Safety Management Teams (SMTs), contributing to benefit–risk assessments and mitigation strategies. •DSURs, PBRERs, RMPs, IBs, and safety sections of clinical study reports •Provide expert medical input for regulatory filings and interactions, including INDs, NDAs/BLAs, and safety responses to agency queries. •Support inspection readiness and audit activities related to clinical safety documentation. Qualifications: •Deep knowledge of GCP, ICH E2E, GVP modules, and global regulatory safety expectations •Demonstrated success in leadership across phase I-IV studies and familiarity with post-marketing surveillance processes •Specialty training in relevant therapeutic areas a plus •Excellent strategic thinking, problem-solving, and influencing skills •Deep knowledge of FDA, EMA, PMDA and other regulatory body interaction •The Ideal Candidate Displays The Following Professional Competencies •Senior-level leadership and communication skills •Strategic thinker with deep scientific and regulatory knowledge •Sound judgment in risk-benefit evaluation •Demonstrated capacity to make decisions in uncertainty Compensation: •$318,000 - $388,000 / year •Competitive benefits and rewards package •Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity •All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $318,000 - $388,000 per year. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!