Executive Medical Director, Oncology Clinical Sciences

Executive Medical Director, Oncology Clinical Sciences

Location:

Cambridge, MA

Join Takeda as an Executive Medical Director in our Cambridge office, where you will contribute to a patient‑focused, innovation‑driven company committed to delivering better health worldwide.

The Executive Director (ED) is responsible for ensuring ongoing review and agreement of therapeutic area strategy and associated documents formulated by the Oncology Therapeutic Area Unit (OTAU) prior to approval by appropriate governance committees. The ED oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP), reviews synopses, clinical study documents, and critical study results, and provides leadership and oversight of clinical development activities.

• Provide strategic clinical input to the Oncology Clinical Science Head for assigned studies.
• Lead the Global Development Team across the US, EU, and other regions, managing both the US/EU Development Team and the Japan/China Development team for assigned compounds.
• Oversee study physicians and/or clinical scientist leads responsible for the conduct and data review of program studies, ensuring proactive identification of risks and contingency plans.
• Direct Development Team strategy and deliverables, overseeing the Development Strategy, Clinical Plan, and Clinical Protocols, recommending scope, complexity, and size that influence the program budget.
• Provide continual critical evaluation of the development strategy to maintain a state‑of‑the‑art development plan that aligns with regulatory requirements, proactively identifying challenges and developing contingency plans.
• Make high‑impact global decisions on data interpretation, medical and scientific implications, and recommendations that affect regional and global development, including go/no‑go decisions and study design modifications.
• Plan clinical development strategies considering medical/clinical significance, treatment landscape, standard of care, and unmet medical needs.
• Ensure regional strategies and trade‑offs are articulated in global strategy documentation and stakeholders are appropriately briefed.
• Provide strategic input into global development strategies and plans for all compounds in OTAU.
• Support evaluation of external compounds (alliances and in‑licensing opportunities).
• Serve as the primary interface with the Medical Affairs team for strategy and product commercial efforts.
• Contribute to the creation and maintenance of the regional KOL network.
• Recommend GDT leader nominations and reviewer selections for external compounds as part of business development.
• Liaise with Clinical Operations and Project Management to coordinate logistics, study planning, and implementation.
• Critically review Synopses, protocols, IBs, and relevant clinical documents for assigned compounds.
• Assess overall safety information alongside Pharmacovigilance and Medical Monitor for assigned compounds.
• Oversee and lead all clinical science activities involving interactions with FDA, other regulatory agencies, and key opinion leaders.
• Evaluate external interactions within overall development strategies, applying complex problem solving in a global context.
• Identify challenges proactively and develop contingency plans.
• Evaluate potential business development opportunities in the region within a global context.
• Conduct due diligence on clinical development plans for potential alliances and in‑licensing opportunities.
• Serve as the clinical contact point for ongoing alliance projects, interfacing with partners to achieve Takeda’s strategic goals.
• Assign and manage clinical science staff involved in these activities.
• Interact directly with the research division based on clinical and developmental expertise, leading internal and cross‑functional teams.
• Work with functional leadership to prioritize projects within the therapeutic area.
• Hire, manage, mentor, motivate, develop, and retain staff; conduct performance reviews and drive goal setting and development planning.

• MD or combined MD/PhD or internationally…