- To facilitate a seamless transition of assets through the Takeda s CNS (Neurology / Psychiatry) R&D portfolio through deep engagement in discovery, seamless transition between discovery/preclinical into clinical research, fulfilling the key fulcrum of bidirectional translational research, and driving the global TREC plan
- To act as the nexus for other TREC functions to execute efficiently on the Early Clinical Research Plan to allow early informed decisions
- To develop and drive the global 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.
- A key objective is to elevate early proof-of-mechanism (POM) and proof-of-concept (POC) studies through innovative thinking that drives integrated, rapid and effective experiments to support Go/NoGo development decisions.
- Acts as a key interface between the CNS 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 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 CNS 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 CNS 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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- MD, MD/PhD preferred
- Formal clinical training, including fellowship training with CNS specialization as well as translational/experimental medicine expertise preferred.
- Clinical development experience should be in academia and/or industry including early clinical trial design and implementation, documentation / filing.
- Discovery/basic research experience is preferred.
- Academic clinical experience is preferred.
- A rigorous record of scientific publication is required.
- Minimum 3-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience.
- Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development.
- Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback.
- Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision.
- Planning, priority setting, and time management are essential.
- Accountability takes responsibility for their own performance and accept full ownership of issues, problems, and opportunities, regardless of the source.
- Comfort with ambiguity is required.
- Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others' ideas.
- Excellent communication, interpersonal sensitivity, and negotiating skills
- Team-work, partnership and collaboration skills
- CNS-related clinical expertise
- Basic and clinical science of CNS pathophysiology
- Translational medicine, including biomarkers
- Nonclinical and clinical drug discovery and development
- Regional/global Regulatory requirements
- Position based in Cambridge, MA or San Diego, CA
- Ability to drive to or fly to various meetings or client sites, including overnight trips and international travel.
- Up to 20% travel time required.
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