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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Executive Medical Director, Oncology Clinical Sciences in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
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:
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Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.
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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.
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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.
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Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical
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Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program.
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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.
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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.
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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.
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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.
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Providing strategic input into global development strategies and plans for all compounds in OTAU.
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Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities)
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Primary interface with Medical Affairs team for strategy and to support of product commercial efforts
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Contributing to the creation and maintenance of regional KOL network
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Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts
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Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation
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Consistent with membership of the Clinical Review Board Committee, responsible for critical review of Synopses, protocols,
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IBs and relevant clinical documents relating to studies in assigned compounds.
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Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.
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Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds.
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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.
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Proactive identification of challenges and development of contingency plans as appropriate.
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Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment.