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/Director Translational and Biomarker Research- CNS in our Cambridge, MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director/ Directorworking on the Translational and Biomarker Research -CNS team, you will be empowered to work with cross-functional teams and lead the biomarker strategy, and a typical day will include:
This position seeks an acknowledged translational and biomarker technical and strategic scientific expert with a strong Neuroscience background and experience in the clinical development of CNS drugs. The primary role is to provide translational and biomarker leadership as well as research planning and decision making from pre-candidate nomination through Proof of Concept (PoC) and Late Stage Clinical testing, for biomarker strategy, discovery and development in the CNS therapeutic area. Responsibilities include partnering with drug discovery scientists and project teams for identification and implementation of pharmacodynamic biomarkers indicating target engagement, hypotheses for patient enrichment and back translation of clinical patient biomarker data to inform future drug discovery. The scientist will also take the lead in keeping up-to-date on, and providing scientific expertise regarding, non-clinical and early clinical biomarker identification and translational pharmacology initiatives.
- Provide strategic, technical and scientific leadership for biomarker development.
- Lead scientific discussions with clinical medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy Synthesize large amounts of complex data to build 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. Lead the collaborative interactions between early clinical development and drug discovery researchers to facilitate generation and implementation of early clinical development strategies.
- Situational leadership of Global Product Teams (GPT) in the biomarker selection for first-in-human studies, provide pharmacologic and pharmacodynamic rationales and translational approaches for early clinical protocols.
- Oversee the design and implementation of biomarker research in clinical trials and monitor the scientific quality of pharmacodynamic and predictive biomarker clinical assay data
- Represent Takeda nationally and internationally when working with academic institutions, competitor pharmaceutical companies and fee-for-service bio analytical companies in the field of translational and biomarker research.
- Identify, evaluate, develop and communicate/negotiate criticality of 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, clinical study reports, biomarker reports and documents submitted to Regulatory Agencies for large global or complex regional 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. Actively manage and participate in industry and academic consortia
- Establish and maintain scientific dialog with clinical translational experts in medical, academic and regulatory communities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Ph.D + 7 years is expected in CNS scientific area.
- 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
- Experience/knowledge base in neuropsychiatric and neurological disorders
- 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
- 20% National and International travel.
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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