Scientific Manager, Scientist I, Biomarker Science & Technologies

Takeda Pharmaceutical Company • Boston, MA

406d • Remote

About The Position

The Scientific Manager, Scientist I, Biomarker Science & Technologies at Takeda is a pivotal role within the Biomarker Science and Technologies (BST) department. This position focuses on project management and operational strategies to support clinical bioanalytical and biomarker scientific operations. The role involves collaboration with various stakeholders across the organization to ensure high-quality clinical data delivery and effective management of biomarker deliverables for concurrent clinical trials.

Requirements

• PhD in a scientific discipline, or MS with 6+ years experience, or BS with 8+ years experience.
• Knowledge of drug development and clinical trial principles.
• Experience in sample management activities across multiple projects.
• Ability to work with diverse groups of scientists, clinicians, and vendor labs.
• Excellent written, organizational, and interpersonal communication skills.
• Working knowledge of FDA & ICH/GCP regulations and clinical laboratory specimen handling.
• Experience with Labmatrix or equivalent sample management software is a plus.
• Proven critical reasoning skills for problem identification and resolution.

Nice To Haves

• Knowledge of regulations from regions such as China and Brazil.

Responsibilities

• Accountable for project management and process-related strategies for the BST sub-team.
• Oversee operational deliverables for different therapeutic modalities across Takeda's portfolio.
• Work closely with clinical biomarker, diagnostics, and bioanalytical sciences groups within BST.
• Coordinate assigned studies and programs by managing timelines and facilitating communication between BST scientists and CRO labs.
• Contribute to bioanalytical and biomarker outsourcing strategy and vendor oversight.
• Develop efficient processes for execution of bioanalytical and biomarker activities.
• Ensure vendor compliance and data integrity by understanding Quality Assurance requirements.
• Support efforts to build strategic relationships with QA&C, clinical operations, and other key functions.

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 accrual (up to 80 hours per year)
• Paid vacation accrual (up to 120 hours for new hires)

What This Job Offers

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