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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

biomarker operationsbiosample managementclinical study designsample logisticsdata managementrisk managementworkflow designprotocol developmentassay validationtranslational research

Soft Skills

communicationorganizational skillsinterpersonal skillsproblem-solvingproject managementteam collaborationresourcefulnessadaptabilityleadershipexecution

Certifications

PMP CertificationPh.D. in biological scienceM.S. in biochemistryB.S. in biological science