Associate Director, Global Aggregate Reporting & Risk Management Plans

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.

The Associate Director, Global Aggregate Reporting & Risk Management Plans supports the strategic and operational execution of pharmacovigilance activities related to aggregate reporting and risk management planning across Madrigal’s portfolio. This role is responsible for hands-on preparation, coordination, and review of aggregate safety reports and risk management plans, ensuring high-quality, compliant, and timely safety deliverables.

Reporting to the Senior Director, Global Aggregate Reporting & Risk Management Plans , this role works cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Biostatistics, Medical Affairs, and external pharmacovigilance vendors to support global safety requirements and maintain a robust safety infrastructure. The Associate Director brings strong pharmacovigilance expertise, scientific judgment, and operational rigor, and plays a key role in scaling safety processes within a dynamic, growing biopharma environment.

Key Responsibilities

• Serve as primary author for assigned aggregate safety reports (e.g. Development Safety Update Reports [DSURs], Periodic Adverse Drug Experience Reports [PADERs], Periodic Benefit-Risk Evaluation Reports [PBRERs]) and Risk Management Plans (RMPs) by coordinating process steps from drafting through finalization for submission.
• Serve as a key contributor to the maintenance and tracking/monitoring of the company Core RMP and regional RMPs as new safety data emerge
• Under the direction of the Senior Director, support global marketing authorization submissions and responses to regulatory information requests from a pharmacovigilance perspective
• Ensure adherence to SOPs, global regulatory requirements, and inspection readiness for aggregate reporting and RMP activities
• Identify opportunities for process improvements and contribute to the continued optimization of aggregate reporting and RMP processes
• Other duties as assigned

Required & Desired Qualifications

• Specialized Knowledge and Skills
  • Demonstrated experience planning, coordinating, and executing aggregate safety reports (e.g., DSURs, PADERs, PBRERs)
  • Working knowledge of the development, maintenance, and lifecycle management of Core and Regional RMPs
  • Solid understanding of global pharmacovigilance regulations and reporting requirements
  • Strong scientific and clinical acumen with the ability to synthesize safety data and clearly communicate risk
  • Highly organized, detail-oriented, and capable of managing multiple deliverables in a fast-paced environment
  • Effective collaborator with the ability to work across matrixed teams and with external vendors
  • Comfortable operating with increasing autonomy while escalating issues appropriately
  • Ability to apply SOPs consistently and support compliance with evolving regulatory expectations
  • Proficient with electronic safety systems and document management tools (e.g., Argus, document authoring platforms)

• Educational Requirements
  • Minimum Bachelor’s degree in a relevant scientific discipline required
  • Advanced degree preferred (e.g., PharmD, PhD, NP/PA)

• Experience
  • Minimum of 10 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry
  • Demonstrated experience contributing to aggregate safety reporting and risk management activities
  • Prior experience working with safety databases and systems (e.g., Argus)
  • Previous experience supporting global regulatory submissions is a plus
  • Previous experience collaborating with external vendors is a plus

• Travel
  • Up to 10% travel may be required

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands.  As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $167,000- $204,000 per year.  We comply with all applicable minimum wage laws.

Full-time employees are eligible for bonus, equity and comprehensive benefits including flexible paid time off (in the form of 4 weeks’ vacation time, 1-week sick time, and 2 float days), medical, dental, vision and life/disability insurance, and leave benefits in accordance with federal, state, and local laws. We also offer Voluntary benefits like life insurance, retirement benefits i.e.  401(k), pre-paid legal and supplemental insurance. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact (HR Contact Information).

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.

Applications are being accepted on an ongoing basis, and can be submitted through our Madrigal Careers site.

Please be aware that we have received 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.

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 or on behalf of Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.  

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. 

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. 

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. 

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. 

Please be aware that we have received 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.  

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 or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com.