|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, Translational Biomarker Research in our Cambridge office.|
As an Associate Director working on the Translational and Biomarker Research -Oncology team, you will be empowered to work with cross-functional teams and lead the biomarker strategy, and a typical day will include:
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
- 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
- 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.
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.
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.
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, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:
+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,
than 7 years of relevant industry experience in translational research and
expertise in Biomarker discovery and development and Translational Medicine as
demonstrated by publications, regulatory submissions and/or national or
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
understanding of PoC and PoM clinical concepts
and trial design
serve as a highly credible technical expert to outside functional areas
understanding of drug development, regulatory processes and early clinical
leadership abilities and proven ability to lead a team within a matrix
organization as well as work independently
analytical, problem solving skills
oral and written communication skills
- 25% 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
No Phone Calls or Recruiters Please.