Madrigal Pharmaceuticals

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. 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).

Senior Manager, Clinical Safety

Department: Research and Development

Location: Hybrid, 3 days a week in Conshohocken office

Reports to: Director, Clinical Safety

Position Summary:

Reporting to the Director, Clinical Safety, the Senior Manager, Clinical Safety is responsible for supporting the ongoing safety evaluation of investigational products through collaboration with cross-functional teams, safety surveillance, case review, and regulatory reporting. This role will assist in the execution of the clinical safety strategy across the product lifecycle, with a focus on the analysis of individual and aggregate safety data, review of clinical trial safety documentation, and support for regulatory submissions.

The position requires strong scientific and clinical judgment, attention to detail, and experience in global pharmacovigilance and drug development processes.

Key Responsibilities:

• Serve as a clinical safety lead on assigned clinical studies
• Collaborate with internal functional areas and external vendors to support SAE case processing and Sponsor review
  • Contribute to the assessment of causality, seriousness, and expectedness of clinical trial AEs/SAEs
  • Provide review of case narratives for accuracy and completeness
  • Review and interpret the information received from medical records is appropriately entered into the ICSRs
• Perform ongoing reviews of clinical safety data for assigned studies
• Collaborate with safety vendors to ensure quality and compliance in case processing and reporting
• Contribute to the development of Safety Documents, e.g. Safety Management Plan
• Contribute to the development of regulatory documents including:
  • Development Safety Update Reports (DSURs)
  • Safety sections of Clinical Study Reports (CSRs) and
  • Investigator Brochures (IBs)
• Contribute to the identification and preparation of case packets for adjudication
• Collaborate with Regulatory Affairs, Clinical Development, Clinical Operations, and Data Management to ensure alignment on safety deliverables and timelines for assigned studies
• Contribute to inspection readiness activities and support audits or health authority inspections as needed
• Ensure adherence to global regulations, company SOPs, and best practices in clinical safety
• Contribute to the Data Monitoring Committee activities, as needed
• Other duties as assigned

Qualifications & Skills Required

• Bachelor’s degree in relevant scientific discipline. Clinical experience (eg RN, BSN, or PharmD) is preferred but not required.
• Clinical safety professional with minimum 7 years of relevant experience within clinical safety and pharmacovigilance
• Experience with clinical trial safety oversight and regulatory safety documentation
• Working knowledge of global pharmacovigilance regulations (e.g., ICH E2A/B, FDA, EMA)
• Familiarity with safety databases (e.g., Argus, ARISg), clinical trial data systems (e.g. RAVE) and MedDRA and WHO Drug coding
• Familiarity with reviewing clinical study protocols and product IB
• Strong clinical understanding of clinical safety and pharmacovigilance principles
• Ability to analyze and interpret safety data from clinical trials
• Excellent attention to detail and commitment to high-quality deliverables
• Collaborative mindset with strong cross-functional communication skills
• Comfortable operating in a fast-paced, evolving biotech environment
• Proactive approach to identifying potential safety issues and recommending solutions

Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.