Takeda Pharmaceutical Company - Boston, MA
posted about 2 months ago
Full-time - Senior
Remote - Boston, MA
Chemical Manufacturing
About the position
The Director Translational Biomarker Lead for Inflammation/Autoimmune Disease at Takeda Pharmaceutical is a strategic leadership role focused on developing and implementing translational biomarker strategies for clinical programs. This position involves collaboration with various teams to identify and validate biomarkers, ensuring their integration into clinical studies. The role requires a deep understanding of drug development processes and aims to drive innovation in biomarker research to enhance patient outcomes.
Responsibilities
- Provide scientific and strategic leadership in developing translational biomarker strategies for Inflammation and Autoimmune diseases.
- Partner with discovery research and physician scientists to design and execute Translational Research for biomarker discovery and validation.
- Lead the Translational subteam and collaborate across multiple functional areas to build consensus for biomarker strategies.
- Represent Translational and Biomarker Research on Project and Global Product Teams, supporting 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 clinical documents and submissions to Regulatory Agencies.
- Support Business Development by evaluating in-licensing opportunities and liaising with external organizations.
Requirements
- 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, with managerial experience preferred.
- Expertise in inflammation and autoimmune diseases, particularly in translational and biomarker research.
- Recognized expertise in biomarker discovery and development, demonstrated through 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 research.
- 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.
