Executive Medical Director, Oncology Clinical Sciences

Role Summary

Executive Medical Director, Oncology Clinical Sciences, based in Cambridge, MA, leads the global oncology development strategy and provides strategic clinical input on assigned studies. The role oversees cross-regional development teams, guides the Integrated Disease Area Strategy and Integrated Global Development Plan, and collaborates with Medical Affairs and regulatory partners. Travel is expected up to 25% to support global development activities.

Responsibilities

• Provide strategic clinical input on assigned clinical studies under the Oncology Clinical Science Head.
• Lead the Global Development Team (US, EU, and others), overseeing US/EU and Japan/China Development teams for assigned compounds, and ensure proactive contingency planning and risk mitigation.
• Direct Development Team strategy and deliverables, including Development Strategy, Clinical Development Plan, and Clinical Protocols; influence scope, complexity, and budget; maintain a state-of-the-art development plan aligned with regulatory requirements and contingency planning.
• Make high-impact global decisions interpreting data from ongoing studies, assess medical and scientific implications, and recommend modifications to development plans or study designs; plan strategies in the context of medical significance and standard of care.
• Ensure regional strategies and trade-offs are articulated in global strategy documentation and that stakeholders are appropriately briefed.
• Provide strategic input into global development strategies and plans for all OTAU compounds; support evaluation of external compounds (alliances and in-licensing opportunities).
• Serve as the primary interface with Medical Affairs for strategy and to support product commercialization efforts.
• Contribute to the creation and maintenance of regional KOL networks; provide recommendations for GDT leader nominations and external reviewers as part of business development.
• Liaise with Clinical Operations and Project Management for coordination of logistics, study planning and implementation.
• As a member of the Clinical Review Board Committee, conduct critical review of synopses, protocols, IBs and other relevant clinical documents for assigned compounds.
• Review and assess overall safety information with Pharmacovigilance and the Medical Monitor of record for assigned compounds.
• Oversee and lead clinical science activities in interactions with FDA, other regulatory agencies, and key opinion leaders relevant to assigned compounds.
• Evaluate external interactions within overall development strategies, using complex problem solving in regional contexts within a global environment; identify challenges and develop contingency plans.
• Evaluate potential business development opportunities in the region within a global framework; conduct due diligence evaluations of clinical development plans for alliances or in-licensing opportunities.
• Serve as the clinical contact point for ongoing alliance projects and interface with partners to achieve Takeda’s strategic goals while maintaining strong relationships.
• Assign and manage clinical science staff; lead TGRD internal teams and global cross-functional teams; prioritize projects within the therapeutic area in collaboration with functional leadership.
• Hire, manage, mentor, motivate, empower, develop and retain staff; conduct performance reviews and drive goal setting and development planning.

Qualifications

• Required: MD or combined MD/PhD or internationally recognized equivalent with a minimum of 10 years of pharmaceutical research experience, including at least 7 years in phase I–IV clinical development.
• Preferred: Training and experience in hematology and/or medical oncology, especially hematologic malignancies.
• Preferred: Previous experience leading a clinical development team/matrix team with studies across multiple regions; development experience beyond US/EU is a plus.
• Preferred: NDA/MAA/submission experience.
• Preferred: Experience with and ability to lead and manage highly trained medical, scientific and technical professionals.
• Required: Superior communication, strategic thinking, interpersonal and negotiating skills.
• Required: Ability to proactively predict issues and solve problems.
• Required: Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Required: Diplomacy and positive influencing abilities across multinational business cultures.

Skills

• Strategic clinical leadership and global development planning.
• Cross-functional team leadership across US, EU, and Asia-Pacific regions.
• Regulatory liaison and pharmacovigilance collaboration; interaction with FDA and other agencies.
• External collaboration with Medical Affairs, business development, and alliance management.
• Regional KOL network development and maintenance; stakeholder management and negotiation.
• Data interpretation for go/no-go decisions and development plan optimization.

Education

• MD or MD/PhD or internationally recognized equivalent.

Additional Requirements

• Travel: Willingness to travel; approximately 25% travel; overnight trips; some international travel may be required.