Director, Translational Biomarker Lead
4 weeks ago
Takeda is seeking a highly skilled and experienced Director, Translational Biomarker Lead to join our team in Boston, MA. As a key member of our Translational Medicine team, you will be responsible for developing and executing translational biomarker strategies to support our clinical stage portfolio in liver disease, including NASH, AATD, and MASH fibrosis.
Key Responsibilities- Partner with our GI-DDU discovery research and physician scientists to design and execute translational research to discover and validate targeted pathways based on human data and to define candidate biomarkers for mechanism 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 the 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.
- Contribute as a key member of the project teams that provide strategic, technical, and scientific leadership for progression of 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 of 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 documents, clinical protocols, 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 with Regulatory Agencies, as required.
- Establish and maintain scientific dialog with KOLs and clinical translational experts in medical, academic, and regulatory communities.
- PhD degree in a scientific discipline with 10+ years of experience, or MS with 16+ years of experience, or BS with 18+ years of 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 communication, problem-solving, and interpersonal skills.
Takeda is a patient-focused company that inspires and empowers its employees to grow through life-changing work. We are a global top employer and strive for excellence in everything we do. Our company culture is inclusive, collaborative, and committed to delivering better health and a brighter future to people around the world.
BenefitsTakeda offers a competitive compensation package, including a base salary range of $169,200.00 - $266,200.00, as well as a range of benefits, including medical, dental, vision insurance, a 401(k) plan, and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
Equal Employment OpportunityTakeda is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating a diverse and inclusive workplace and are proud to be a global top employer.
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