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Associate Director Translational Biomarker Lead
4 months ago
**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** R0122759**Date posted** 05/20/2024**Location** Boston, MassachusettsAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director Translational Biomarker Lead Inflammation/Autoimmune disease, ECD in our Cambridge, MA offices.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver **_Better Health and a Brighter Future_** to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
This position requires acknowledged technical and strategic leadership with managerial experience. The primary role is to provide scientific and strategic leadership developing the translational biomarker strategy, plans and to secure implementation for Inflammation and Autoimmune (AI) diseases 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. Responsible for independently developing 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. Secure implementation and delivery of data.
ACCOUNTABILITIES
- 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 and 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.
**DIMENSIONS AND ASPECTS**
**Technical/Functional (Line) Expertise**
Outstanding expertise and depth of knowledge within inflammation and Autoimmune diseases translational and biomarker space
- Keeps up with the up-to-date scientific advancement (e.g. competitive landscape, new technology, new research portfolio, and new partnership)
**Leadership**
Has significant organizational leadership responsibility, including primary responsibilit
