Translational Operations Manager
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Job Description
Translational Operations Manager at Enveda transforming natural compounds into life-changing medicines. Leading biomarker and clinical operations, enhancing drug discovery processes.
Responsibilities:
- 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
- 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
- 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
- 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
Requirements:
- 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
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