This position is an acknowledged technical and strategic expert whose primary role is to provide scientific leadership, research planning and decision making from Pre-Candidate Nomination (CN) through Proof of Concept (PoC) and Late Stage Clinical testing, for smaller global or large regional compounds relevant to their therapeutic area for biomarker discovery and clinical development. Responsibilities include partnering with DDU scientists and research project teams to identify biomarkers relevant to clinical patients, providing scientific expertise to generate clinical development strategies including clinical biomarkers in collaboration with the Translational Research Network for the Global Product and/or Early Development Teams. These strategic goals include implementation of pharmacodynamic biomarkers indicating target engagement, hypotheses for patient enrichment and feedback of clinical patient data to DDU. Takes the lead in keeping up-to-date on, and providing scientific expertise regarding, non-clinical and early clinical biomarker identification and translational pharmacology initiatives.
- Collaborate with medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy.Part of the team that provides strategic, technical and scientific leadership for development, implementation and data interpretation of an integrated translational research strategy for assigned program(s).
- Partner with DDU scientists to design and execute translational research to discover and validate pathways and biomarkers associated with mechanism of action and drug response. Participate in the collaborative interactions between Early Clinical Development and DDU researchers in Shonan Research Center, Takeda California, Takeda Cambridge and Takeda Singapore to facilitate generation and implementation of early clinical development strategies.
- Represent Translational Research on Global Product Teams (GPT) working groups to contribute to the dose and biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational/experimental medicine approaches for early clinical protocols.
- Participate in the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
- Maintain extensive knowledge of the research and development efforts from academic institutions, competitor pharmaceutical companies and fee-for-service bioanalytical companies for relevant oncology biomarkers.
- Evaluate, and use new scientific tools for effective and thorough non-clinical and early clinical programs and ensure that technical and scientific standards meet state-of-the-art industry expectations.
- Responsible for the preparation and review of biomarker sections of candidate nomination documents, clinical protocols and documents submitted to Regulatory Agencies for smaller global or larger regional assigned compounds.
- Support Business Development efforts by evaluating potential in licensing opportunities and serve as a liaison with external companies, organizations, consultants, university representatives, NIH, and with FDA, as required. Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Ph.D +10 years, or PharmD +12 years, or Masters +13 years or Bachelors +15 years Degree is expected in relevant scientific area, e.g., Oncology, Immunology, Neurobiology, Endocrinology, Pharmacology, Biochemistry, Molecular Biology, Cell Biology.
- More than 7 years of relevant industry experience in translational research and assay development
- Recognized expertise in Biomarker discovery and development and Translational Medicine as demonstrated by publications, regulatory submissions and/or national or international presentations
- Must be capable of utilizing the highest scientific and technical standards for the successful design and execution of translational research strategies implemented in early clinical programs in a timely manner
- An understanding of PoC and PoM clinical concepts and trial design
- Should serve as a highly credible technical expert to outside functional areas
- Excellent understanding of drug development, regulatory processes and early clinical development
- Strong leadership abilities and proven ability to lead a team within a matrix organization as well as work independently
- Superior analytical, problem solving skills
- Extraordinary oral and written communication skills
- Exceptional interpersonal skills
- 25% National and International travel.
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Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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