Director, Global Clinical Safety

Madrigal Pharmaceuticals•Conshohocken, PA

9d•$213,000 - $260,000

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. Position Summary: Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the Director, Global Clinical Safety will play a key role in overall clinical safety strategy, safety assessment, evaluation and risk management of products in various stages of development as well as involvement in all safety surveillance activities and communication of regulatory safety topics for assigned products.

Requirements

Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
Experience in managing external teams
Excellent written and verbal communication skills
Excellent in detailed-oriented tasks
Ability to interpret health and medical records such as adverse event reporting forms, discharge summary, etc.
Good knowledge of pharmacovigilance reporting rules and timelines
Experience with clinical case processing, including MedDRA and WHO Drug coding and narrative writing
Prior experience in designing safety and PV processes highly desirable
Experience with safety databases; Argus is a plus but not mandatory
Experience with EDC for clinical trial data collection
Bachelor’s degree in relevant scientific discipline.
Minimum 12 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry inclusive of case quality control and regulatory submissions of ICSRs worldwide
Minimum 3 years of direct or indirect people management experience

Nice To Haves

Clinical experience (e.g., BSN, or PharmD) is preferred, but not required.

Responsibilities

Serve as clinical safety lead for assigned products.
Oversee pharmacovigilance vendor activities including but not limited to collection, monitoring, assessment, evaluation, and tracking of safety information for assigned products.
Assist with the safety assessment, evaluation and risk management in various stages of clinical development as well as the continuous efficient evaluation of adverse events and all other safety information.
Manage and interface with outside service providers, business partners and vendors for clinical safety around patient safety related tasks.
Provide medical review (providing medical expertise and judgement) of ICSRs for the products assigned.
Responsible for the collection of data and preparation of the case reports for submission of cases to Adjudication Committee
Responsible for Data Monitoring Committee activities for assigned products, including but not limited to the preparation of the quarterly meeting presentation
In collaboration with pharmacovigilance aggregate reporting team, assist with completion of clinical trial periodic reports, e.g., IND Annual Reports, Development Safety Update Reports (DSURs), for assigned products.
Support the aggregate reporting team in providing consistent communication of safety topics across all regulatory safety documents for assigned products.
Provide support to the assigned safety surveillance lead for signal detection and evaluation of trends.
Assist with other PV activities as required