Scientist, Translational Medicine

About The Role

Focuses on operational delivery of assigned Therapeutic Area (TA) activities, including vendor coordination, contract and budget tracking, and use of project management tools to ensure high-quality, on-time data delivery. Supports execution through vendor selection, fit-for-purpose method development and validation, integration into clinical protocols, and sample testing at CROs, working closely with Translational Medicine, Clinical Operations, and external partners.

• Support clinical TA operations for First In Human (FIH) and early-phase studies in alignment with Translational Medicine strategies
• Coordinate day-to-day activities with CROs and external vendors (assay laboratories) and support clinical assay development/validation
• Track vendor contracts, scopes of work, budgets, and timelines
• Use Smartsheet, Excel, and other project management tools to track deliverables, risks, and dependencies
• Support integration of operational plans into clinical protocols and study execution plans
• Monitor vendor performance and elevate risks/issues impacting timelines, quality, or budget
• Collaborate cross-functionally with Translational Medicine, Outsourcing, Clinical Operations, Regulatory, Quality Assurance, Data Management, and others
• Plan, implement, and execute clinical specimen collection, testing, and data delivery
• Maintain accurate documentation for GxP compliance; support inspection readiness
• Provide regular status updates and support additional operational activities as needed

• BS/BAMS in Biology, Chemistry, or related field with 2+ years relevant industry experience OR MS with some relevant experience OR PhD with some relevant industry experience
• Operational rigor and attention to detail; meet multiple deadlines with accuracy/efficiency
• Strong execution mindset; ability to anticipate and manage risks
• Collaborative, team-oriented; translate scientific/operational requirements into plans
• Strong written and verbal communication
• Experience supporting FIH or early-phase clinical studies
• Experience working with CROs/external laboratories; support clinical assay development and sample testing
• Strong organizational/project management skills;
  Smartsheet preferred
• Familiarity with clinical biomarker workflows and early clinical development
• Working knowledge of GxP requirements and biomarker/bioanalytical operations