Executive Medical Director, Oncology Clinical Sciences

Objectives

The Executive Director (ED) is responsible for ensuring ongoing review and agreement of the therapy area strategy and associated documents formulated by the Oncology Therapeutic Area Unit (OTAU) prior to their review and 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) while also responsible for the review of synopses, other relevant clinical study documents, and critical study results. He or she will provide leadership and oversight of respective clinical development activity, including the management of a team of individuals responsible for the conduct of clinical trials within a program. He or she is also responsible for providing guidance to OTAU leaders on regional specificities within the therapeutic area.

Accountabilities

• Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.
• Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/China Development team for assigned compounds.
• Oversees the study physician(s) and/or clinical scientist(s) leads responsible for the conduct and data review of program studies.
• Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.
• Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols.
• Recommends scope, complexity and size, which influence the budget of all aspects of a program.
• Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
• Responsible for 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 modification of development plans or study designs that may have a significant impact on timelines or product labeling.
• Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.
• Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed.
• Providing strategic input into global development strategies and plans for all compounds in OTAU.
• Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities).
• Primary interface with Medical Affairs team for strategy and to support of product commercial efforts.
• Contributing to the creation and maintenance of regional KOL network.
• Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts.
• Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation.
• Consistent with membership of the Clinical Review Board Committee, responsible for critical review of Synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds.
• Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
• Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds.
• Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment.
• Proactive identification of challenges and development of contingency plans as appropriate.
• Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment.
• Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities.
• Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
• Assigns and manages clinical science staff who are involved in many of these activities.
• Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area.
• Leads TGRD internal teams and global cross-functional teams.
• Works with functional leadership to prioritize projects within the therapeutic area.
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.
• Conducts performance reviews and drive goal setting and development planning.

Education, Experience, Knowledge and Skills

• MD or combined MD/PhD or internationally recognized equivalent 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 a plus.
• NDA/MAA/Submission experience strongly preferred.
• Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred.
• Superior communication, strategic, interpersonal and negotiating skills.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities across multinational business cultures.

Travel Requirements

Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 10% travel.