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 an Associate Director in Translational Biomarker Research (TBR)-GI Therapeutic Area in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director in TBR-GI Therapeutic Area working on the Translational Research & Early Clinical team, you will be empowered to be the strategic biomarker lead for GI programs and lead project teams and a typical day will include:
This position requires an acknowledged technical and strategic expert whose primary role is to provide scientific leadership, research planning and decision making in drug development programs. The programs would range from Pre-Candidate Nomination through clinical Proof-of-Concept and Late Development. Responsibilities include partnering with drug discovery scientists and research project teams to identify biomarkers relevant to patients in clinical studies, 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, developing and testing hypotheses for patient enrichment and feedback of clinical patient data to drug discovery scientists. In addition, the candidate should be able to provide current scientific expertise regarding, non-clinical and early clinical biomarker identification and translational pharmacology approaches. For Late Stage and On-market drugs, the candidate should be able to utilize of biomarker data generated in clinical studies and phase 0 studies in collaboration with the GPT and Medical Affairs, to expand the use of the drugs, as co-therapies, treatment for new patient populations and for new disease areas.
- 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 drug discovery 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 drug discovery researchers at multiple sites (Japan, UK, Singapore) to facilitate generation and implementation of early clinical development strategies.
- Represent Translational Research on Global Product Teams (GPT) 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 GI 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.
- Support Medical Affairs and Late Stage development for identifying potential ways that the approved indication can be expanded.
- 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, EXPERIENCE, 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., GI, Immunology, 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 Proof-of-Concept and Proof-of-Mechanism 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
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
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, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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