Senior Director, Global Aggregate Reporting and Risk Management Plans na Madrigalpharma

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).

Job Summary:

The Senior Director Global Aggregate Reporting & Risk Management Plans is a key leader responsible for providing strategic oversight and operational leadership of pharmacovigilance activities across Madrigal’s aggregate reporting and risk management plans. This individual will build and develop processes for the development, maintenance and tracking/monitoring aggregate reporting and risk management plans, playing a key role in ensuring patient safety. The role will also support global filings (e.g. Marketing Authorization Applications) from a pharmacovigilance perspective. The role will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Medical Writing, Biostatistics, and external PV vendors as appropriate to maintain a compliant and efficient safety infrastructure. This role requires deep pharmacovigilance expertise, sound clinical judgment, and an owner mindset to scale PV capabilities in a dynamic, growing biopharma environment.

Position Specific Responsibilities:

The key responsibilities for this role are:

• Leads review of aggregate data and author/oversee aggregate reports and Risk Management Plans (RMPs), and safety sections of global Marketing Authorization Applications
• Ensure a company core RMP is in place and maintained as new safety data becomes available to serve as the company position when filing in new global markets
• Provides scientific and regulatory guidance on adverse event assessment, benefit-risk evaluation, risk management planning
• Leads/Oversees and contributes to the preparation and review of key safety deliverables, including:
  • Development Safety Update Reports (DSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Risk Management Plans (RMPs)
  • Safety sections of INDs, NDAs, MAAs, BLAs, CTAs

• Ensure consistent application of SOPs, regulatory compliance, and audit/inspection readiness
   

Specialized Knowledge & Skills:

• Proven ability to plan, coordinate and successfully execute preparation of aggregate safety reports (e.g. DSUR, PADER, PBRER, etc)
• Extensive experience preparing, maintaining and tracking/monitoring the content of Core and Regional Risk Management Plans (RMPs)
• Experience preparing Clinical Safety documents for global MAA submissions (e.g. Integrated Summary of Safety, Summary of Clinical Safety, etc.) and Information Request responses
• Demonstrated ability to ensure governing SOPs are compliant with global regulatory requirements
• Anticipates the necessary resources are available for planned and ad hoc aggregate reports, RMPs and Information Requests to ensure high quality, timely deliverables
• Extensive experience managing team and/or vendors responsible for aggregate reports and RMPs
• Deep understanding of pharmacovigilance principles and regulatory frameworks across global markets
• Strong scientific and clinical acumen, with the ability to synthesize safety data and communicate risk clearly
• Skilled at building relationships and influencing across matrixed environments
• Excellent organizational skills with high attention to detail and operational rigor, with comfort managing ambiguity and evolving infrastructure
• Highly experienced in mentoring, developing, and scaling pharmacovigilance teams and processes
• Possesses computer skills to support use of electronic systems and development of writing deliverables

Educational Requirements:

• Minimum Bachelor's degree in relevant scientific discipline required
• Advanced degree preferred: PharmD, PhD, NP/PA

Experience:

• Minimum 15 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry
• Minimum of 5+ years of direct and indirect people management experience
• Familiarity with safety systems (e.g., Argus) and EDC platforms

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 [email protected]. 

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 [email protected].