James Canavan MD PhD FFPM FRCP FRCPI

Clinical Development Leader

Cambridge, Massachusetts, United States

About

I am a pharmaceutical physician and drug development leader. I am passionate about developing new medicines that meet unmet medical needs and improve quality of life for patients with serious diseases. I have broad experience in early and late-phase clinical development, including leadership on assets that have gone on to receive marketing authorization in multiple geographies. I combine evidence generation with a cross-functional understanding of medical-, regulatory- and commercial strategy, and an imperative to demonstrate differentiation and added value, tailored to the needs of major markets. I enjoy leading matrixed teams to drive results, mentoring colleagues, and helping others succeed in their roles.

Experience

  • Disease Area Lead at Takeda
    Sep 2025 - Present · 11 mos

    Executive Medical Director leading Late-Phase Clinical Development for the Gastrointestinal & Inflammation TAU's General Gastroenterology Disease Area: Takeda's portfolio of assets in development for gastroenterology, hepatology and metabolism indications, beyond Vedolizumab and Zasocitinib. Role includes line management, mentoring and coaching Clinical Research Physicians and Clinical Research Scientists, ownership of functional deliverables and Disease Area strategy, deep cross-functional support for asset teams, and contribution to development tactics and strategy for multiple early-phase assets.

  • Sr. Clinical Program Lead at Boehringer Ingelheim
    Dec 2023 - Sep 2025 · 1 yr 10 mos

    Cross-functional team leader in immunology clinical development. I work in a fast-moving, early phase environment and my assets follow the science to find their niche in whichever indications they can provide the greatest benefit to patients, including gastroenterology, rheumatology, dermatology and diabetes. I also have an above-asset strategy role within the immunology team, and I enjoy mentoring and contributing to career development within the organization.

  • Bristol Myers Squibb (4 yrs 2 mos)
    • Executive Director, WW Medical Affairs
      Oct 2021 - May 2023 · 1 yr 8 mos

      Worldwide Medical Affairs team lead for ZEPOSIA (ozanimod; S1PR modulator, small molecule) in UC. Leading Medical strategy (incl. functional planning and budgeting; maintaining alignment with WW Commercial), Medical tactics (incl. supporting launch in multiple geographies, medical education, advisory boards, thought leader engagement), and Medical evidence generation (incl. post hoc analyses of Phase 3 and OLE studies; Phase 4 studies; real-world evidence; investigator sponsored research). Direct reports.

    • Clinical Development Lead
      Apr 2019 - Sep 2021 · 2 yrs 6 mos

      Clinical development lead for SOTYKTU (deucravacitinib; BMS-986165; TYK2 inhibitor, small molecule) for inflammatory bowel disease indications. Role included functional accountability for clinical development strategy, clinical development plan, development and conduct of 4 Phase 2 clinical trials in adults, and pediatric development (PIP, iPSP); including thought leader interactions, developing and managing trial steering committees, DSMB and supporting regulatory interactions.

  • Medical Advisor / Senior Medical Advisor at Eli Lilly and Company
    Jul 2016 - Mar 2019 · 2 yrs 9 mos

    Clinical development physician for mirikizumab (LY-3074828; anti-IL-23p19 antibody, biologic) in IBD. Role included supporting Phase 2 & 3 clinical trials; End of Phase 2 activities; Phase 3 protocol development and study conduct; Regulatory interactions (FDA and EMA/HTA advice); Novel endpoint development.

  • Advanced Fellow in Inflammatory Bowel Disease at Brigham and Women's Hospital
    Jul 2014 - Jun 2016 · 2 yrs