Sam Madison

About Sam Madison

Resourceful, versatile leader with over 20 years’ experience in the pharmaceutical industry. Has a diverse background including all phases of clinical development with a strong background in Hepatology, Oncology, Infectious Disease, Aesthetics, Immunology and Virology. Demonstrated abilities include presentations, strategy, study management, project management and personnel management as well as a proven track record for exceeding customer expectations, effective strategic planning, and organization. Extensive experience leading complex projects and programs of related clinical studies. Great interpersonal skills and success leading large, high profile client relationships within the clinical research industry. Outstanding relationship builder across all levels of the organization, from front-line to the C-suite. Experience working in companies from small start-ups to multi-billion dollar organizations. A confident and detail-oriented high performer with tenacity and excellent communication skills.

Experience

1. Director, Clinical Research

   Intercept Pharmaceuticals

   Sep 2022 — Present

   Program Director Responsibilities- Lead and drive the design and execution of Phase 1 / Phase 2 / Phase 3 clinical trials- Provide scientific expertise and support to externally facing groups- Contribute to departmental resource planning, budgeting, and timeline setting tomeet company needsClinical Development Duties- Responsible for developing clinical strategy in alignment with the Commercial andR & D strategies to sustain the pipeline- Create budgets, timelines and workstreams for the approval of early phase assets- Ensure the optimal planning,implementation and interpretation of clinical studies to advance the pipeline- Provide oversight to the development and maintenance of clinical developmentplans for early stage compounds- Provide direction and oversight to the planning, conduct, review, and interpretationof clinical trials- Contribute to the strategic planning, authoring, and review of regulatorydocuments; Support regulatory interactions- Provide oversight into scientific data disclosures including publications andcommercial support documents- Build productive relationships with investigators, key opinion leaders, and keystakeholders in the medical/scientific community- Lead development of specific topics of interest such as those for discussion atadvisory boards - Collaborate with Business Development in the identification, early evaluation, anddue diligence of opportunities for investment or acquisition- Provide input on the development of new compounds and therapeutic areas ofinterest- Contribute to the preparation of clinical protocols, study reports, IND, IB, NDA/CTDdocuments- Interact and support Medical Affairs and Commercial activities- Commercial/Medical Affairs Duties- Design, create content for and staff the R&D/Medical Affairs booth at variousscientific conferences- Visit potential and current clinical sites to provide information, direction andguidance on clinical trial participation

Education

• East Carolina University

  Master of Science (MSc), Immunology/Molecular Biology

  1991 — 1997

• East Carolina University

  Bachelor of Science (BS), Cell/Cellular and Molecular Biology

  1991 — 1993

Skills

• U.s. Food and Drug Administration (Fda)
• Immunology
• Project Management
• Strategy
• Clinical Research
• Oncology
• Ctms
• Regulatory Submissions
• Leadership
• CRO Management
• Pharmaceutical Industry
• Management
• Clinical Development
• Pharmaceuticals
• Biotechnology
• Drug Development
• Hiv/Aids
• Gcp
• Infectious Diseases
• Strategic Planning
• Medical Affairs
• Clinical Trials