Associate Director, Global Health Economics & Outcomes Research (RWE)
Madrigal Pharmaceuticals · United States
Job Description
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 Health Economics & Outcomes Research (GHEOR), Real-World Evidence (RWE) will support the strategic goals of the GHEOR, Global Medical Affairs (GMA) and the broader business driving patient access with optimal pricing and reimbursement for Madrigal Pharmaceutical’s medicines, with a focus on Rezdiffra. This position directly impacts the ability to achieve business objectives on a global basis by providing strategic guidance and robust evidence development relevant to achieve optimal patient access by demonstrating the value of our medicines for liver health, with a primary focus on developing and deploying real-world data and evidence to support Rezdiffra and the Madrigal portfolio, in a federated operating model that includes service delivery across the enterprise. This role will be responsible for developing and executing RWE projects and strategies against the global integrated evidence plans, including dissemination of technical deliverables related to real-word data and evidence. The role will also support the design and execution of pragmatic, prospective real-world and implementation science studies to evaluate treatment effectiveness, care delivery and adoption of evidence-based practices in routine clinical settings. Reporting to the Senior Director, GHEOR (RWE), the incumbent will be working closely with the GMA, Clinical Development & Biostatistics, Access and Commercial, Regional and in-Country teams to foster a culture that promotes innovation, optimal population health and patient centricity. All incumbents are responsible for adhering to applicable Madrigal policies and procedures. Key Responsibilities and Primary Activities: Approximately 60% of this role focuses on executing functional objectives, and the remaining 40% is dedicated to providing support for strategic direction and adapting priorities to achieve organizational goals.
- Evidence Generation and HEOR Studies
- Analyze complex real-world data (RWD) sources such as administrative claims and electronic health records databases
- Design, build, and maintain internal data warehouses
- Develop and maintain reproducible analytical pipelines and real-world evidence (RWE) platforms using R programming, leveraging version control tools and collaborative coding environments (e.g., GitHub), while integrating SQL and Python where beneficial
- Build and govern internal real-world data (RWD) analytics infrastructure by leveraging modern platforms such as Posit Workbench and Databricks to enable end-to-end RWE study execution
- Execute both rapid analyses and full protocol-driven research studies, including retrospective observational, prospective real-world, pragmatic and implementation science studies, ensuring methodologies are robust, fit-for-purpose and scientifically sound
- Support the design and execution of pragmatic and implementation studies that evaluate real-world treatment effectiveness, adoption of evidence-based practices, care pathways, treatment initiation, adherence and persistence, and patient outcomes in routine clinical practice
- Leverage advanced analytic and statistical modeling techniques (e.g., Cox regression, propensity score matching, IPTW) to drive causal inference and integrate data across diverse real-world sources
- Navigate complex datasets to leverage data that improves patient outcomes
- Clinical and Regulatory Support
- Ensure RWE studies adhere to FDA and EMA regulatory guidance to produce high-quality evidence supporting label expansion and HTA submissions
- Partner with cross-functional stakeholders—including Medical Affairs, regulatory, access, clinical and data science teams—as well as external investigators and healthcare-system partners, as appropriate, to inform RWE, pragamatic and implementation research across the product lifecycle
- Industry & Conference
- Stay current on industry trends and advancements in RWE, HEOR, pragmatic research and implementation science methodologies
- Present at scientific conferences and publish in key journals
- Compliance & Quality
- Ensure all activities comply with company SOPs, industry standards, and applicable regulations
- Uphold the highest ethical standards in all external engagements
- Travel Requirement
- Travel up to 30% for scientific congress attendance, internal and external meetings
- Ability to work across global time zones as needed
- Graduate degree in biostatistics, public health, epidemiology, or a similar field
- 10-12+ years of relevant experience.
- In-depth experience with R programming, version control and collaborative development tools (e.g., GitHub), and analytic environments such as Posit Workbench, Databricks or similar cloud-based data science platforms
- Expertise in applying advanced statistical analytic methodologies to RWD
- Familiarity with common commercially available RWD data assets encompassing administrative claims and EHR databases
- Experience in delivering ad-hoc and full protocol-driven observational studies; experience with prospective real-world research, pragmatic studies, implementation science or health services research is preferred
- Experience with liver / metabolic diseases in the RWD space would be preferred
- A strong track record of publications
- Strong communication skills
- High proficiency with project management systems, Medical Affairs dashboards, CRM platforms, and enterprise collaboration tools (e.g., Veeva, Microsoft Office Suite, SharePoint, Teams, Zoom)
- PhD preferred
- Experience with SQL and Python
- In-depth knowledge of liver disease; experience in cardiometabolic health or metabolic dysfunction-associated steatohepatitis (MASH)
Details
| Company | Madrigal Pharmaceuticals |
| Location | United States |
| Type | FULL TIME |
| Niche | general |
| Experience | full-time |
