Translational Operations Manager

What You’ll Do

• Lead end-to-end biosample and biomarker operations for Phase 1 SAD/MAD and Phase 2 clinical studies, as well as earlier-stage translational work
• Develop biomarker sampling schemas, protocol sections, lab manuals, and kit specifications in collaboration with Translational Medicine and Clinical Operations
• Coordinate biomarker assay development, validation, and sample management activities, involving all relevant internal and external stakeholders and ensuring technical feasibility
• Manage end-to-end biospecimen lifecycle: sample collection, site training, shipment logistics, processing, and data transfer between internal teams and external partners
• Partner with leaders and scientists across translational science, biology, clinical development, and CRO/vendor organizations to plan and execute biomarker operations
• CRO & Vendor Management
  • Serve as the primary liaison with CROs for study design, execution, and reporting; monitor data quality and deliver concise, actionable readouts to internal teams
  • Select and oversee central and specialty biomarker labs, managing vendor contracting, SOWs, POs, timelines, and data deliverable milestones
  • Manage CRO and vendor relationships for biomarker assay outsourcing, sample logistics, and translational study execution
• Data Management & Reporting
  • Partner with Data Management to ensure clean, reconciled, analysis-ready biomarker datasets are delivered on time to support dose selection, mechanism validation, and study design decisions
  • Implement and optimize tracking systems and LIMS tools to manage workflows, sample inventory, and operational exceptions
  • Develop reusable SOPs, tracking tools, and reconciliation workflows to scale operations across the portfolio
  • Create dashboards and reports for communication of biomarker study progress, sample inventory, and assay timelines
  • Clearly communicate the status of projects, challenges, results, and proposed paths forward across internal and external stakeholders, teams, and time zones
• Program & Timeline Management
  • Lead timelines and deliverables across multiple R&D programs spanning early discovery through clinical development
  • Turn scientific and commercial goals into clear, testable plans with explicit decision gates
  • Proactively manage risks and maintain tight coordination across R&D, CMC, and external partners
  • Ensure tasks and projects are delivered on-time, within scope and within budget through constant communication and follow-up with stakeholders
  • Assist Project Leaders in meeting management through agenda planning, providing status updates, and following up on action items
  • Explore opportunities for accelerating timelines and ensure resource availability and allocation

We’re Looking For

• B.S./M.S./Ph.D. in a biological science, biochemistry, or related translational discipline; PMP Certification is a plus
• 3+ years of experience managing biomarker or translational research projects, including hands-on Phase 1 and/or Phase 2 clinical study experience, CRO/vendor oversight, and sample operations
• A strong executor who can manage end-to-end biospecimen logistics and proactively mitigate risk related to timelines, protocol deviations, and sample integrity
• Vendor-savvy operator comfortable selecting and overseeing central and specialty labs, including contracting and SOW management
• A systems thinker who can design workflows, configure tracking tools and LIMS, and manage operational exceptions
• Excellent oral and written communication skills and strong organizational, interpersonal, and problem-solving abilities
• Technologically savvy and motivated to learn new project productivity software
• Comfortable working in a fast-paced, dynamic, results- and team-oriented startup environment across multiple geographies
• Resourcefulness to do more with less in a startup environment

At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. Apply now and join a team committed to shaping the future of drug discovery.