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 Clinical Safety Associate II

Department: Research and Development

Location: Hybrid, 3 days a week in Conshohocken office

Reports to: Director, Clinical Safety

About Madrigal:

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra™ (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Madrigal is seeking to become a global biopharmaceutical company and to bring Rezdiffra™ (resmetirom) to patients with nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH).

The company is in an exciting period of rapid growth and has made the decision to expand its clinical safety capabilities to match the company’s ambitions.

Position Summary:

Reporting to the Director, Clinical Safety, the Senior Clinical Safety Associate is responsible for assisting the Clinical Safety Protocol leads with the tracking and quality review of ICSRs from clinical studies and supporting the Clinical Safety team in maintaining subject safety and regulatory compliance across investigational products.

Key Responsibilities:

• Responsible for handling incoming ICSR notifications which include but are not limited to:
  • Tracking the ICSR notification and ICSR review completion
  • Notifying the Safety team of potential expedited ICSRs
  • Follow up with the Safety vendor to ensure expedited ICSRs are submitted as per regulatory requirements
  • Perform quality review of ICSRs including accurate coding of the SAE and medical history using MedDRA, ensuring the narrative is accurate and complete, identifying possible discrepancies between the source documents and the ICSR
• Responsible for the weekly reconciliation between the vendor safety database and Sponsor tracking system and providing feedback to vendor of discrepancies
• Responsible for weekly review of open ICSRs and outstanding safety queries, notifying the vendor of any discrepancy
• Assist with the Development Safety Update Report (DSUR) as requested by management
• Participate in clinical safety team and safety vendor meetings
• Responsible for distributing and tracking meeting minutes with vendors and monthly reports
• Responsible for tracking laboratory alerts for assigned clinical studies and follow until resolution
• Assisting with providing safety information when requested by management
• Assist with tracking cases and collecting safety information for adjudication
• Ensure adherence to global regulations, company SOPs, and best practices in clinical safety
• Assist with inspection readiness and support audits or health authority inspections as needed
• Other duties as assigned

Qualifications and Skills Required:

• Bachelor’s degree in relevant scientific discipline. Clinical experience (eg RN, BSN, or PharmD) is preferred but not required.
• Minimum of 2 years of relevant experience in clinical safety and pharmacovigilance
• Experience with clinical trial safety ICSR processing, writing safety narratives
• 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
• Strong clinical understanding of clinical safety and pharmacovigilance principles
• 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.