Director. Global Clinical Safety Scientist
Madrigal Pharmaceuticals · Conshohocken -, PA
Clinical OperationsFull-time$213k–$260kCompany career page
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Role summary
Madrigal Pharmaceuticals seeks a Director of Global Clinical Safety Scientist to lead safety assessments for clinical products in liver disease treatment. The role involves collaborating with cross-functional teams on regulatory submissions, safety data analysis, and pharmacovigilance activities.
What they're looking for
- Minimum 12 years of clinical safety or pharmacovigilance experience in pharma/biotech
- Bachelor's degree in relevant scientific discipline; advanced degree preferred
- Strong knowledge of global safety regulations and MedDRA terminology
- Experience contributing to regulatory submissions (IND, NDA, MAA)
- Proficiency with safety databases and clinical trial data systems
- Excellent analytical, written, and verbal communication skills
- Experience leading cross-functional or matrixed teams
What you'll be doing
- Serve as lead safety scientist for assigned clinical development projects
- Author and review safety sections of protocols, informed consent forms, and regulatory submissions
- Analyze and summarize clinical safety data for data review committees and study reports
- Collaborate with pharmacovigilance physician on safety signal identification and regulatory responses
- Create and present safety data reviews for internal committees and technical teams
Privacy & handoff
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