Associate Director Translational Biomarker Lead Inflammation/ Autoimmune Disease, ECD GI - TAU
Company: Takeda
Location: Boston
Posted on: October 22, 2024
Job Description:
Job DescriptionAbout the role:At Takeda, we are a
forward-looking, world-class R&D organization that unlocks
innovation and delivers transformative therapies to patients. By
focusing R&D efforts on four therapeutic areas and other
targeted investments, we push the boundaries of what is possible in
order to bring life-changing therapies to patients worldwide.Join
Takeda as an Associate Director, Translational Biomarker Lead
Inflammation/ Autoimmune Disease, ECD where you will provide
scientific and strategic leadership in developing the translational
biomarker strategy, and plans to secure implementation for
Inflammation and Autoimmune (AI) diseases programs in clinical and
pre-clinical stages of development. This is a highly visible,
strategic, and matrixed role, responsible for leading the
Translational subteam (TST) partnering with Gastro-Intestinal drug
discovery unit (GI-DDU) discovery research and physician-scientists
and relevant partner lines and functions to identify and validate
biomarkers relevant to patients in clinical studies. Responsible
for independently developing translational biomarker strategy and
plans as part of the overall Asset Strategy in the Discovery and
Global Product Teams through all stages of clinical development and
post-market activities. Secure implementation and delivery of data.
As part of the Translational Biomarker Research team, you will
report to the Head of the team and work with the Gastrointestinal
and Inflammation Therapeutic Area Unit (GI - TAU).How you will
contribute:
- Partner with GI-DDU discovery research and physician-scientists
in designing and executing Translational Research to discover and
validate targeted pathways based on human data and define candidate
biomarkers for mechanisms of action and drug response.
- Lead Translational Biomarker strategy development and execution
to support the clinical stage portfolio, including biomarker-driven
clinical study design, implementation of novel technologies, and
incorporation of biomarker endpoints for decision-making in
early-stage clinical trials.
- Lead Translational subteam (TST) and matrix leadership and
collaboration across multiple functional areas, working closely
with physician-scientists, clinical leads, clinical
pharmacologists, BST, discovery research scientists, and
non-clinical and other functions to build consensus for a
fit-for-purpose biomarker strategy.
- Represent Translational and Biomarker Research on Project and
Global Product Teams to provide pharmacodynamic, disease and
predictive biomarker strategies and support translational medicine
goals of the assigned programs in all phases of clinical
development.
- Contribute as a key member of the project teams that provide
strategic, technical, and scientific leadership for the progression
of the program from discovery research through development and
contribute as a subject-matter expert for clinical development and
overall asset strategies.
- Implement fit-for-purpose validation for all clinical biomarker
assays with BST and ensure high scientific quality of
pharmacodynamic, prognostic and predictive biomarker data to drive
program decision-making. Evaluate and utilize state-of-the-art
scientific tools and ensure implementation cutting-edge technology
to drive innovation in the execution of biomarker strategy.
- Maintain extensive knowledge of the research and development
efforts from academic institutions, competitor biopharmaceutical
companies, and fee-for-service bioanalytical CROs for MASH fibrosis
translational biomarker research.
- Responsible for the preparation and review of biomarker
sections of candidate nomination, PRC documents, CDP, clinical
protocols, ICFs and documents submitted to Regulatory
Agencies.
- Support Business Development efforts by evaluating potential
in-licensing opportunities and serve as a liaison with external
companies, organizations, consultants, university representatives,
NIH, and Regulatory Agencies, as required.
- Establish and maintain a scientific dialog with KOLs and
clinical translational experts in medical, academic, and regulatory
communities.Minimum Requirements/Qualifications:
- PhD or MD/PhD degree in a scientific discipline with 8+ years
experience, or
- MS with 16+ years experience, or BS with 18+ years
experience.
- At least 5 years of experience in clinical translational
biomarker research.
- Outstanding expertise and depth of knowledge within
Inflammation and Autoimmune diseases clinical translational and
biomarker space. Dermatology, gastroenterology and/or rheumatology
experience preferred.
- Recognized expertise in biomarker discovery and development and
Translational Medicine as demonstrated by publications, regulatory
submissions, and/or national or international presentations.
- Excellent understanding of drug development, regulatory
processes, and clinical development.
- Strong leadership abilities and proven ability to lead a team
within a matrix organization as well as work independently.
- Strong analytical, oral, and written communication,
problem-solving, and interpersonal skills.More about us:At Takeda,
we are transforming patient care through the development of novel
specialty pharmaceuticals and best-in-class patient support
programs. Takeda is a patient-focused company that will inspire and
empower you to grow through life-changing work.Certified as a
Global Top Employer, Takeda offers stimulating careers, encourages
innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams
are united by an unwavering commitment to deliver Better Health and
a Brighter Future to people around the world.This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policy.
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Keywords: Takeda, Somerville , Associate Director Translational Biomarker Lead Inflammation/ Autoimmune Disease, ECD GI - TAU, Executive , Boston, Massachusetts
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