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Senior Medical Director

Boston, Massachusetts


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Senior Medical Director

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Job ID R0022392 Date posted 08/20/2020 Location Boston, Massachusetts

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Job Description

The Senior Medical Director will lead and drive strategy for the overall global clinical development of TAK-007 taking into consideration the medical, scientific, regulatory and commercial issues. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. 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 TAK-007 in multiple regions as well as inform the value dossiers required for reimbursement. Applies clinical/medical decision making to clinical development issues. This role impacts the ability of Takeda R&D to meet its corporate goals and for Takeda to have future commercial products.


•Clinical Development team participation and leadership. Join the TAK-007 Global Clinical Sub-Team (CST) to ensure that activities are aligned with the global oncology development strategy.

•As a member of the TAK-007 Global CST, establishes and drives strategy and deliverables in the context of the GPT’s TAK-007 Asset Strategy in the specified disease area (e.g. Diffuse Large Cell Lymphoma, Indolent B-cell Lymphoma); leads the generation of the Clinical Development Plan and specified global registration enabling clinical protocol.  Recommends scope, complexity and size, and influences the budget of all aspects of a program.  Provides continual critical evaluation of the Asset 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.

•Synopsis / Protocol Development, Study Execution, & Study Interpretation. Drives TAK-007 clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies.  Serves as an advisor to clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies.  Presents TAK-007 study conclusions to R&D Management and determines how individual study results impact the overall cell therapy strategy. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.

•Study monitoring. Responsible for TAK-007 medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety, in partnership with clinical scientist and CRO responsible for trial delivery.  Assesses overall safety information for TAK-007 studies in conjunction with Pharmacovigilance.  Oversees non-medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding TAK-007 study conduct related to scientific integrity.

•External interactions. Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to TAK-007 in the specified therapeutic area (e.g. DLBCL, iNHL).  These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for TAK-007, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.

•Due Diligence, Business Development and Alliance Projects. Responsible for identification and evaluation of potential business development opportunities in cell therapies, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities.  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. Serves as a clinical contact 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.

•Leadership, Task Force Participation, Upper Management Accountability. Interacts directly with Translational Medicine – Cell Therapies Engine, Oncology Therapeutic Area Unit, and Takeda R&D based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as OTAU scientific content matter expert for TAK-007.  May represent clinical science on multidisciplinary task forces across divisions.   Join Takeda R&D internal teams and may lead global cross-functional teams, as appropriate. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. Coordinate, lead and deliver periodic departmental trainings.


•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).

•Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.

•NDA/MAA/Submission experience preferred.

•Management experience 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

•Therapeutic area knowledge relevant to mechanism of action

•Regional/global Regulatory requirements


•Emerging research in designated therapeutic area


Boston, MA

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Full time

Job ID R0022392

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