Vice President , Global Clinical Lead - Solid Tumor (Hiring Immediately)

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I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead

- Solid Tumor in our Cambridge 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:

Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees.

Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP).

Responsible for review of synopses, other relevant clinical study documents and critical Study Results.

Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area.ACCOUNTABILITIES:

Clinical Development team participation and leadership Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies.Consistent with the Takeda R&D Oncology

Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other

R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regionsPart of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group 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. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. 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 effortsContributing to the creation and maintenance of regional KOL networkProviding recommendations for GDT leader nominations and reviewers of external compounds as part of business development effortsLiaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementationSynopsis / Protocol Development, Study Execution, & Study Interpretation 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. Trial Medical Monitoring Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds.External Interactions 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.Due Diligence, Business Development and Alliance Projects 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.Leadership, Task Force Participation, Upper Management Accountability 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:

ExperienceMD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology

Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially

in solid tumor malignancies Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies.Experience in conducting and/ or leading multiple clinical trials involving immune based therapies

Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment.Demonstrated ability to foster a high-performance culture and build organizational capabilities.Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives.Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EUSolid and Multiple