Senior Medical Director, Clinical Science -Solid Tumor ...
Takeda Pharmaceutical - Boston, MA
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy NoticeandTerms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Join us as a Senior Medical Director, 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. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.The Senior Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for multiple Takeda pipeline compounds. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development issues. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products.Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles. 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: monitoring and 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. A significant error in judgment may result in loss of approvability and/or commercial viability of a product. Drives all Clinical Science department activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Trial Medical Monitoring Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance. Directs activities involved in interactions with regulatory authorites/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives. Due Diligence, Business Development and Alliance Projects Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge/understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. Represents clinical science on high impact/priority task forces across the organization or external to the company. Conducts performance reviews and drive goal setting and development planning.MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is highly preferred Experience in conducting and/ or leading clinical trials in involving immune based therapies and/or antibody drug conjugates is highly preferred Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred Regional/global Regulatory requirements Emerging research in designated therapeutic areaTRAVEL REQUIREMENTS: Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 15 - 25% travel.
Created: 2026-04-02