Associate Director Translational Biomarker Lead

4 weeks ago

Boston, United States ARIAD Full time

**Job Level**:
Senior**Travel**:
Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

**Job ID** R0122758**Date posted** 05/20/2024**Location** Boston, Massachusetts**About 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 where you will provide scientific and strategic leadership developing the translational biomarker strategy, plans and to secure implementation for Liver disease - MASH fibrosis programs in preclinical and clinical stage 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) research and physician scientists and relevant functions to identify and validate biomarkers relevant to patients in clinical studies. You will also independently develop translational biomarker 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. As part of the Gastrointestinal and Inflammation Therapeutic Area Unit (GI²-TAU), you will report to the Head, Early Clinical Development (ECD), GI, and work with GI²-TAU organization.

**How you will contribute**:

- 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 and nonclinical and discovery research scientists to build consensus for a fit-for-purpose biomarker strategy.
- Represent Translational Biomarker Research on Project and Global Product Teams to provide pharmacodynamic, disease and predictive biomarker strategy and support translational medicine goals of the assigned programs in all phases of clinical development.
- 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.
- 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 Regulatory Agencies, as required.
- Establish and maintain scientific dialog with KOLs and clinical translational experts in medical, academic and regulatory communities.

**Minimum Requirements/Qualifications**:

- PhD degree in a scientific discipline with 7+ years experience, or MS with 13+ years experience, or BS with 15+ years experience.
- At least 7 years of experience in translational biomarker research. Managerial experience desired.
- Experience in inflammation and Autoimmune diseases.
- Outstanding expertise and depth of knowledge within Liver disease - MASH fibrosis.
- 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

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