Executive Medical Director, Oncology Clinical Sciences

About the role

The Executive Medical Director (EMD) for Oncology Clinical Sciences at Takeda is responsible for overseeing the therapy area strategy and associated documents, developing and executing the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP), reviewing synopses, clinical study documents, and critical study results. They lead the Global Development Team (GDT) and manage clinical development activities, including study physicians and clinical scientists.

Responsibilities

• Provide strategic clinical input on assigned clinical studies.
• Lead the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/China Development team for assigned compounds.
• Oversee the study physician(s) and/or clinical scientist(s) leads responsible for the conduct and data review of program studies.
• Ensure the development teams are proactively identifying contingencies, potential risks, and strategies to address future obstacles.
• Direct Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan, and Clinical Protocols.
• Recommend scope, complexity, and size, which influence the budget of all aspects of a program.
• Continually evaluate the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
• Make high-impact global decisions, interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as "go/no go" decisions or modifications to development plans or study designs.
• Plan clinical development strategies in context of medical/clinical significance, considering how a given product fits into current treatments, standard of care, and unmet medical needs.
• Ensure regional strategies and trade-offs in regional requirements are well-articulated in the global strategy documentation and that stakeholders are appropriately briefed.
• Provide strategic input into global development strategies and plans for all compounds in OTAU.
• Contribute to the creation and maintenance of regional KOL networks and provide recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts.
• Liaison with Clinical Operations and Project Management for logistics, study planning, and implementation.
• Critical review of Synopses, protocols, IBs, and relevant clinical documents relating to studies in assigned compounds.
• Review and assess overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
• Oversee and lead all clinical science activities involving interactions with FDA, other regulatory agencies, and key opinion leaders relevant to assigned compounds.
• Proactively identify challenges and develop contingency plans as appropriate.
• Evaluate potential business development opportunities in the region with the context of a global environment.
• Conduct due diligence evaluations of clinical development plans for potential alliances and/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 good working relationships with partners.
• Assign and manage clinical science staff involved in these activities.
• Work with functional leadership to prioritize projects within the therapeutic area.
• Hire, manage, mentor, motivate, empower, develop, and retain staff to support assigned activities.
• Conduct performance reviews and drive goal setting and development planning.

Requirements

MD or combined MD/PhD with minimum 10 years pharmaceutical research experience, including minimum 7 years phases I-IV clinical development experience. Training and experience in Hematology and/or Medical Oncology, especially hematologic malignancies is highly preferred. Previous experience in successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Development experience beyond US/EU is a plus. NDA/MAA/Submission experience strongly preferred. Demonstrated ability to lead and manage highly trained medical, scientific, and technical professionals. Superior communication, strategic, interpersonal, and negotiating skills. Proactive issue prediction and problem-solving abilities. Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams. Diplomacy and positive influencing abilities across multinational business cultures. Willingness to travel to various meetings or client sites, including overnight trips. Approximately 10% travel required.

Qualifications

Education: MD or combined MD/PhD or internationally recognized equivalent.

Skills

• Superior communication, strategic, interpersonal, and negotiating skills.
• Proactive issue prediction and problem-solving abilities.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities across multinational business cultures.

Benefits

Takeda offers a comprehensive benefits package including:

• Medical, dental, and vision insurance.
• A 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• A tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.

U.S. based employees may be eligible for short-term and long-term incentives. Additionally, U.S. based employees are eligible to receive up to 80 hours of sick time and 120 hours of paid vacation per calendar year.