Senior Director, Clinical Development

Madrigal Pharmaceuticals•Conshohocken, PA

7d•$330,000 - $403,000

About The Position

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 Senior Director, Clinical Development is a senior physician leader responsible for providing strategic and operational leadership across Madrigal Pharmaceuticals’ clinical-stage pipeline, currently encompassing three programs and seventeen clinical studies spanning early through late-stage development. This role is accountable for shaping and executing integrated Clinical Development Plans (CDPs) that support regulatory approval, lifecycle expansion, and differentiation in metabolic and liver diseases, including MASH. The Senior Director partners cross-functionally to ensure scientific rigor, patient safety, regulatory alignment, and timely execution across the portfolio. This position requires deep medical expertise, strong translational and clinical insight, and the ability to lead complex, multi-study programs in a dynamic biotech environment. The Senior Director collaborates closely with Discovery, Translational Medicine, Nonclinical, CMC, Regulatory, Clinical Operations, Commercial, and external experts to drive high-quality development strategies and deliver meaningful outcomes for patients.

Requirements

MD or MD/PhD required
Board certification in a relevant specialty (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field).
10+ years of clinical development experience across the drug development life cycle with 15+ years of total relevant experience.
Demonstrated success in healthy authority interactions.
Proven ability to design clinical trials and make benefit-risk decisions with limited data.
Effective communicator with strong leadership presence and ability to influence internal and external stakeholders.

Nice To Haves

Experience in liver disease, MASH/NASH, metabolic disorders, cardiometabolic disease, inflammation, or endocrine pathways.
Experience supporting or leading NDA/MAA submissions and/or outcomes studies.
Experience advancing programs from early development through registration in a biotech setting.

Responsibilities

Provide strategic clinical leadership within the three clinical-stage programs and seventeen active studies, ensuring alignment with corporate objectives and long-term value creation.
Lead and oversee integrated Clinical Development Plans (CDPs) from early clinical development through registration and lifecycle management.
Establish clear development milestones, go/no-go criteria, and risk mitigation strategies for the clinical stage program.
Serve as the medical voice for assigned programs at governance forums and executive leadership meetings.
Lead design and medical oversight of Phase I–III clinical trials, including FIH, PoC, registrational, and outcomes studies.
Define clinical endpoints, biomarker strategies, patient populations, statistical assumptions, and differentiation strategies.
Integrate translational, PK/PD, and biomarker data into dosing strategies and clinical decision-making.
Ensure consistency, scientific rigor, and strategic coherence across multiple studies within each program.
Provide medical oversight for ongoing clinical trials, ensuring patient safety, data integrity, and high-quality execution.
Partner with Clinical Operations to ensure operational excellence, enrollment strategy optimization, and proactive issue resolution.
Review emerging data, conduct benefit–risk assessments, and guide adaptive development strategies as needed.
Contribute to safety governance and data monitoring activities.
Serve as Clinical Development subject matter expert regulatory interactions globally (FDA, EMA, and other health authorities), including End-of-Phase meetings, Scientific Advice, and pre-NDA/MAA engagements.
Oversee the medical content and strategic framing of INDs, amendments, briefing books, Investigator Brochures, CSRs, and NDA/MAA submissions.
Anticipate and proactively address regulatory risks, incorporating evolving guidance into development strategy.
Partner with Translational Medicine to refine biomarker strategies, patient stratification approaches, and mechanism-based differentiation.
Collaborate with Nonclinical and CMC teams to support safety packages, manufacturing readiness, and lifecycle planning.
Align with Biometrics on statistical strategy and data interpretation.
Work with Commercial and HEOR teams to ensure TPP alignment, competitive positioning, and value demonstration strategy.
Other duties as assigned