Vice President, Franchise Clinical Lead, Oncology Cambridge, MA Category: Clinical Development

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Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the Oncology Therapeutic Area Unit (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. How you will contribute:Clinical Development team participation and leadershipAccountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studiesConsistent 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 needAccountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefedProviding strategic input into global development strategies and plans for all compounds in OTAUProviding 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 InterpretationConsistent 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 MonitoringReviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compoundsExternal InteractionsOversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compoundsResponsible 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 environmentProactive identification of challenges and development of contingency plans as appropriateDue Diligence, Business Development and Alliance ProjectsResponsible for evaluation of potential business development opportunities in the region but with the context of a global environmentConducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunitiesServes 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 partnerAssigns and manages clinical science staff who are involved in many of these activitiesLeadership, Task Force Participation, Upper Management AccountabilityInteracts 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 areaHires, manages, mentors, motivates, empowers, develops, and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planningSkills and qualifications:MD 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 OncologyStrong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapiesExperience 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 environmentDemonstrated ability to foster a high-performance culture and build organizational capabilitiesStrong leadership commitment to diversity, equity, and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectivesPrevious experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EUStrong experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others Multiple NDA/MAA submission experienceProven ability to lead and manage highly trained medical, scientific, and technical professionalsSuperior communication, strategic, interpersonal, and negotiating skillsEnterprise level leadership with the ability to inspire, motivate and drive resultsExcellent communication both verbally and in writing and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partnersOutstanding executive presence and communication skillsProactively predict issues and solve problemsAbility to drive decision-making within a multi-disciplinary, multi-regional, matrix teamsDiplomacy and positive influencing abilities across multinational business cultures Travel Requirements:Willingness to travel to various meetings or client sites, including overnight trips. Several international travels may be requiredRequires approximately 25-35 % travel Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Cambridge, MAU.S. Base Salary Range:$321,000.00 - $504,460.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. For information about our benefits, please click here.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.