Director. Global Clinical Safety Scientist
Core
Lead safety scientist for assigned projects, developing and maintaining safety assessments for all Madrigal clinical products in conjunction with the CSPV Physician and cross-functional team members.
Role type
Director, Global Clinical Safety Scientist
Builds
Safety assessments, regulatory submissions, and safety data summaries for clinical products targeting metabolic dysfunction-associated steatohepatitis (MASH).
Domain
Biopharmaceuticals / Clinical Safety & Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global safety regulations knowledge, analytical and critical thinking, regulatory submissions experience, safety report authoring, MedDRA and WHO Drug terminology application, safety database management, EDC for clinical trial data collection
Preferred skills
Safety and PV process design, managing external teams, leading cross-functional matrixed teams, Argus safety database experience
Technologies
Argus, EDC
Responsibilities
Author, review, and provide critical feedback to study documents (Protocol, ICF, Investigator's Brochure); Evaluate safety data from clinical studies for internal committees and Clinical Study Reports; Support safety sections of submission filings (IND, NDA, MAA); Collaborate on identification of safety signals and preparation of responses to safety inquiries; Create and present safety slide presentations for technical committees.
Seniority
Director, strategic leadership with hands-on scientific execution
