Takeda Pharmaceutical Company - Boston, MA
posted about 2 months ago
Full-time - Senior
Remote - Boston, MA
Chemical Manufacturing
About the position
The Associate Director, Translational Biomarker Lead for Inflammation/Autoimmune Disease at Takeda is a strategic role focused on developing and implementing translational biomarker strategies for clinical and pre-clinical programs. This position involves leading a translational subteam, collaborating with various functional areas, and ensuring the integration of biomarker endpoints in clinical studies. The role is pivotal in driving innovation and delivering data that supports drug development in the Inflammation and Autoimmune disease therapeutic areas.
Responsibilities
- Provide scientific and strategic leadership in developing the translational biomarker strategy for Inflammation and Autoimmune diseases.
- Partner with GI-DDU discovery research and physician-scientists to design and execute Translational Research for biomarker discovery and validation.
- Lead the development and execution of Translational Biomarker strategy to support clinical stage portfolio.
- Represent Translational and Biomarker Research on Project and Global Product Teams to support translational medicine goals.
- Implement fit-for-purpose validation for clinical biomarker assays and ensure high scientific quality of biomarker data.
- Maintain knowledge of research and development efforts in the biomarker space from various institutions and companies.
- Prepare and review biomarker sections of regulatory documents and clinical protocols.
- Support Business Development by evaluating in-licensing opportunities and liaising with external stakeholders.
Requirements
- PhD or MD/PhD with 8+ years of experience, MS with 16+ years, or BS with 18+ years of experience in a scientific discipline.
- At least 5 years of experience in clinical translational biomarker research.
- Expertise in Inflammation and Autoimmune diseases, with preferred experience in dermatology, gastroenterology, or rheumatology.
- Recognized expertise in biomarker discovery and development, demonstrated by publications and presentations.
- Strong understanding of drug development and regulatory processes.
- Proven leadership abilities in a matrix organization and strong analytical skills.
Nice-to-haves
- Experience with novel technologies in biomarker-driven clinical study design.
- Familiarity with regulatory submissions and interactions with regulatory agencies.
Benefits
- Medical, dental, and vision insurance coverage.
- 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 and well-being benefits.
- Sick time and paid vacation accrual.
