Overview As Associate Director, Global Clinical Safety Scientist, you will lead safety science activities for Madrigal's clinical programs, partnering with CSPV physicians and cross-functional teams. You will shape safety assessments, contribute to study documents and regulatory submissions, and help translate safety data into clear, actionable insights for DRCs, DMCs, and regulators. This role sits at the core of CSPV, enabling safe and effective development of Rezdiffra for MASH. You will work in a collaborative, high-performance environment that values rigorous pharmacovigilance and scientific excellence.
Compensation / Benefits- equity with meaningful opportunity
- comprehensive benefits including medical, dental, vision and life/disability insurance
- flexible paid time off
- retirement options including 401(k) with employer match
- mental health benefits via EAP
- additional voluntary benefits
Responsibilities- Serve as safety scientist for assigned projects, coordinating clinical safety activities and escalating complex safety issues
- Contribute to authoring and reviewing safety sections of study documents (Protocols, ICFs, Investigator's Brochures)
- Provide analytical support to CSPV physician for safety questions during development and protocol design
- Evaluate safety data from studies (TFLs, tables, figures) to support DRCs, DMCs, and CSRs
- Contribute to safety sections of regulatory submissions (INDs, NDAs, MAAs)
- Prepare and present safety data review materials for Technical Committee, Protocol Review Committee, Safety Review Team, etc.
- Collaborate with Safety Surveillance Team to identify safety signals and respond to inquiries from healthcare professionals and regulators
- Collaborate with cross-functional stakeholders on safety documents and safety content development
- Perform additional tasks as directed by management
Key requirements- Good knowledge of global safety regulations
- Strong analytical and critical thinking skills
- Experience contributing to regulatory submissions and safety reports
- Excellent written and verbal communication skills
- Excellent in detailed-oriented tasks
- Ability to interpret health and medical records
- Experience with MedDRA and WHO Drug terminology; narrative writing
- Experience contributing to development or improvement of safety and PV processes is highly desirable
- Experience coordinating with external vendors or partner teams
- Experience working in cross-functional, matrixed teams
- Experience with safety databases; Argus is a plus but not mandatory
- Experience with EDC for clinical trial data collection
- strong communication
- cross-functional collaboration
- attention to detail
- MedDRA
- WHO Drug terminology
- safety databases (Argus)
