Senior Medical Director
2 days ago
Philadelphia
About the Role The Senior Director, Clinical Development will be a senior physician-leader responsible for providing strategic and operational leadership across the 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 that support regulatory approval, lifecycle expansion, and differentiation in metabolic and liver diseases, including MASH. The Senior Director will partner 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 will collaborate 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. Key responsibilities include providing strategic clinical leadership, overseeing integrated Clinical Development Plans, and ensuring alignment with corporate objectives and long-term value creation. Responsibilities Portfolio & Program Leadership • 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. Clinical Strategy & Study Design • 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. Study Oversight & Execution • 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. Regulatory Strategy & Engagement • 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. Cross-Functional Collaboration • 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. Qualifications • MD or DO required; board certification in a relevant specialty (Internal Medicine, Gastroenterology, Endocrinology, Hepatology, or related field)., • 5+ years of clinical development experience across the drug development life cycle., • 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. Required Skills • Experience in liver disease, MASH/NASH, metabolic disorders, cardiometabolic disease, inflammation, or endocrine pathways preferred., • Experience supporting or leading NDA/MAA submissions and/or outcomes studies., • Experience advancing programs from early development through registration in a biotech setting., • Enterprise & Portfolio Leadership experience., • Ability to think beyond individual studies to create integrated, portfolio-level clinical strategies that maximize long-term value., • Designs robust development pathways across early and late stages, balancing speed, differentiation, and regulatory success. Preferred Skills • Translational & Hypothesis-Driven Thinking., • Deep understanding of mechanism of action, biomarker strategy, and patient segmentation across development stages., • Data-Driven Decision-Making., • Interprets complex and evolving datasets to make disciplined, timely benefit–risk decisions., • Cross-Functional Influence., • Builds strong partnerships across Clinical, Regulatory, CMC, Commercial, and Executive Leadership., • Communicates highly complex medical and statistical concepts clearly to diverse stakeholders., • Makes timely, data-driven decisions in ambiguous scenarios., • Maintains high accountability for trial integrity, data quality, and clinical outcomes., • Builds strong KOL relationships and represents the company externally with scientific and medical rigor. Pay range and compensation package Details regarding pay range or salary or compensation are not specified in the provided job description. Equal Opportunity Statement We are committed to diversity and inclusivity in our hiring practices.