Manager, Biomarker Operations

Dispatch Bio • Philadelphia, PA

15d

About The Position

The Biomarker Operations Manager will be responsible for the operational execution of the biomarker plan defined by Translational Sciences across preclinical and clinical programs. This role ensures high-quality, on-time delivery of biospecimen management, biomarker assay implementation, data flow, and vendor oversight to support clinical development and regulatory objectives. The ideal candidate is highly organized, detail-oriented, and comfortable operating in a fast-paced, high-efficiency biotech environment.

Requirements

• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• At least 5 years of experience in biomarker operations, translational research, clinical operations, or laboratory project management
• Hands-on experience managing biomarker activities in clinical trials
• Strong understanding of biospecimen handling, laboratory workflows, and clinical trial operations
• Experience working with external vendors and CROs
• Excellent organizational, communication, and problem-solving skills

Nice To Haves

• Experience in oncology, cell therapy, gene therapy, or immunology
• Familiarity with regulatory expectations for biomarker data (e.g., FDA, EMA)
• Experience in early-stage or small biotech environments
• Knowledge of sample tracking systems, clinical data standards and LIMS (e.g., Benchling)

Responsibilities

• Plan, execute, and track biomarker activities across clinical studies, including sample collection, handling, storage, shipment, testing, and data delivery.
• Translate biomarker strategy into operational plans, timelines, and budgets.
• Support implementation of exploratory, pharmacodynamic, pharmacokinetic, and safety biomarkers.
• Oversee biospecimen logistics, including site training, sample collection kits, chain of custody, and reconciliation.
• Ensure compliance with protocol, ICH/GCP, and applicable biosafety and ethical requirements.
• Maintain accurate sample inventories and documentation.
• Manage external vendors (e.g., central labs, specialty labs, CROs).
• Oversee contracts, SOWs, timelines, deliverables, and budgets for biomarker-related vendors.
• Serve as primary operational point of contact for biomarker vendors.
• Oversee internal lab sample receipt, accessioning, storage, and chain-of-custody documentation.
• Partner closely with Clinical Operations, Translational Sciences, Research, Data Management, Regulatory, and Quality teams.
• Support protocol development, informed consent language, and clinical operations manuals related to biomarker activities.
• Contribute to study team meetings and program-level planning.
• Ensure timely and accurate transfer of biomarker data to internal teams and data management systems.
• Support data review, query resolution, and integration with clinical datasets.
• Contribute to clinical study reports, regulatory submissions, and scientific communications.
• Develop and maintain work instructions, SOPs, workflows, and templates for biomarker operations.
• Identify opportunities to improve efficiency, quality, and scalability of biomarker execution.
• Support inspection and audit readiness related to biomarker activities.

Benefits

• We offer a highly competitive compensation package with meaningful ownership through equity
• Excellent coverage for medical, vision, and dental
• 401(k) with generous contribution
• Life insurance
• Flexible PTO policy
• Additional substantial benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Manager