Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior/Executive Medical Director, TREC Clinical Sciences (TCS) Gastroenterology (GI) in our Cambridge office.
Senior/Executive Medical Director, TREC Clinical Sciences (TCS) Gastroenterology (GI)
Based at our R&D Headquarters in Cambridge, MA, this role reports in to the TCS-GI VP who reports in to the SVP of the cross-functional Translational Research and Early Clinical (TREC) organization.
- Manage and develop members of the GI-TCS group.
- Contribute to development of overall GI translational strategy across multiple disease areas (motility, inflammatory bowel disease, liver disease, celiac disease).
- To provide a key fulcrum of bidirectional translational research for the GI portfolio
- To facilitate a seamless transition of assets through the Takeda s GI R&D portfolio, through deep engagement in discovery and seamless transition between discovery/ preclinical into early clinical research
- To lead Translational Strategy Teams consisting of other Research and Clinical scientists to develop an Early Clinical Research Plan, including design and oversight of preclinical and translational studies that will best inform clinical development
- To lead other TREC functions in further development and execution of the Early Clinical Research Plan in a way that drives quantitative, disciplined Go/NoGo decisions earlier in development, based on Early Proof-of-Concept (EPOC) studies (biomarker driven, ideally in segment patient populations)
- To develop and drive the TREC plan as part of the overall Asset Strategy in the Global Project Team
- This role embraces the principles of a translational/exploratory mindset, with a focus on operational excellence, and deep scientific rigor.
- Acts as a key interface between the GI Drug Discovery Unit (DDU) and Therapeutic Area Unit (TAU) to ensure portfolio prioritization and seamless transition of programs between research and clinical development, as part of the overall Asset Strategy of the Global Project Team (GPT).
- Drive projects to rigorous assessments of therapeutic success or failure by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible by the POM / POC stage of development.
- Leads Clinical Subteam or manages other department who leads clinical subteam of GPT to provide the key pivot of POM / POC that informs future scientific, medical, and business program approaches and Go/NoGo decisions.
- Engages early (at lead optimization stage) with GI DDU to assist in research portfolio prioritization, based in part on translation strategy.
- Provides early clinical expertise and recommendations to DDU on go/no-go decisions at candidate decision gates.
- Serves on (and/or Leads) the Translational Subteam of the GPT to support biomarker, imaging, and/or pharmacogenomic strategies and implementation.
- Creates the Early Clinical Research Plan (ECRP), integrating input from other functions across TREC (as needed), including Translational Biomarker Research, Imaging, Quantitative Clinical Pharmacology, Early Clinical Operations, and Genomic Medicine.
- Coordinates with other functional experts within TREC to utilize all modalities required to accelerate or enhance the decision-making process
- Designs and implements clinical protocols for first in human studies through POM and/or early POC.
- Ensures that critical TREC experiments deliver timely Go/No-Go decisions.
- Engages GI TAU during ECRP creation to ensure early clinical studies support decision making for late phase development.
- Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as well as co-authored publications in scientific journals.
- Ensures agile, timely management of issues arising from ongoing studies, including serving as the study physician for adverse event reporting.
- Works closely with early clinical operations, quality, procurement, and contracting groups to support study team implementation of early phase clinical studies.
- Provides clinical expertise for early phase external opportunities and participate in due diligence teams.