Director. Global Clinical Safety Scientist

Madrigal Pharmaceuticals•Conshohocken, PA

1d•$213,000 - $260,000•Onsite

About The Position

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety Scientist will play a key role within Clinical Safety & Pharmacovigilance (CSPV) to develop and maintain safety assessments for all Madrigal clinical products in conjunction with the CSPV Physician and cross-functional team members.

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 and its application, and narrative writing
Minimum Bachelor’s degree in relevant scientific discipline required.
Minimum 12 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry inclusive of experience as a Safety Scientist

Nice To Haves

Prior experience in designing safety and PV processes highly desirable
Experience in managing external teams
Experience leading cross-functional matrixed teams
Experience with safety databases; Argus is a plus but not mandatory
Experience with EDC for clinical trial data collection
Clinical experience (e.g., BSN, or PharmD) is preferred, but not required.
Advanced degree preferred: PharmD, PhD, NP/PA, or Master’s with relevant experience

Responsibilities

Serve as the lead safety scientist for assigned projects
In collaboration with CSPV physician, author, review and provide critical feedback to relevant sections of study documents including Protocol, Informed Consent Form (ICF), Investigator’s Brochure
Provide research support to CSPV physician for safety questions that arise during clinical development, protocol development or determine appropriate safety mitigations
Evaluate safety data from clinical studies [ex. excel files or Tables, Figures & Listings (TFLs)] including analysis and summary of key safety findings for internal Data Review Committees (DRCs), Data Monitoring Committee (DMC) meetings, and Clinical Study Reports (CSRs) (i.e. actual assessment of safety data)
Support safety sections of submission filings and regulatory responses including but not limited to IND, NDA, and MAA
Create and present safety slide presentations of data reviews for Technical Committee, Protocol Review Committee, Safety Review Team, etc.
Collaborate with Safety Surveillance Team on the identification of safety signals from clinical trials, analysis and authoring of safety data summaries, and preparation of responses to safety inquiries from healthcare professionals and regulatory agencies
Collaborate with cross-functional stakeholders in development of context, review, and finalization of documents
Collaborate with CSPV physician in the development of safety content by applying knowledge of safety profile and summarizing relevant findings
Perform additional tasks, as directed by management