Director Translational Biomarker Lead Liver Diseases MASH and Liver Fibrosis, ECD GI² TAU

Takeda Pharmaceutical Company • Cambridge, MA

403d • Remote

About The Position

The Director, Translational Biomarker Lead at Takeda is a strategic and highly visible role responsible for developing and implementing the translational biomarker strategy for liver diseases programs in both preclinical and clinical stages. This position involves leading a translational subteam and collaborating with various research and clinical scientists to identify and validate biomarkers that are crucial for clinical studies. The role requires independent development of biomarker plans as part of the overall asset strategy and participation in project teams to provide scientific leadership throughout the clinical development process.

Requirements

• PhD or MD/PhD in a scientific discipline with 10+ years of experience, or MS with 16+ years, or BS with 18+ years of experience.
• At least 7 years of experience in translational biomarker research.
• Outstanding expertise in liver diseases translational and biomarker space.
• Recognized expertise in biomarker discovery and development as demonstrated by publications and 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.

Nice To Haves

• Managerial experience is desired.
• Experience with MASH and liver fibrosis is preferred.

Responsibilities

• Partner with GI² DDU research scientists and GI² TAU physician scientists to design and execute Translational Research for biomarker discovery and validation.
• Lead the development and execution of the Translational Biomarker strategy to support clinical stage portfolio and clinical study design.
• Manage the Translational subteam (TST) and collaborate across multiple functional areas to build consensus for biomarker strategies.
• Represent Translational Biomarker Research on Project and Global Product Teams to support translational medicine goals.
• Contribute strategic and technical leadership for program progression from discovery research through development.
• Implement validation for clinical biomarker assays and ensure high scientific quality of biomarker data.
• Evaluate and utilize state-of-the-art scientific tools to drive innovation in biomarker strategy execution.
• Prepare and review biomarker sections of candidate nomination documents and clinical protocols.
• Support Business Development by evaluating in-licensing opportunities and liaising with external organizations and regulatory agencies.
• Establish and maintain scientific dialogue with KOLs and clinical translational experts.

Benefits

• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Sick time and paid vacation accrual

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree