- Location:Needham, MA (Hybrid office schedule)
- Salary: $161-$175k
Position SummaryCandel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations to oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical development programs.
This role will partner closely with Translational Medicine, Clinical Operations, Data Management, Clinical Development, Regulatory Affairs, Statistics, and external vendors to ensure high-quality, compliant, and inspection-ready biospecimen operations throughout the clinical trial lifecycle.
Key Responsibilities- Serve as the operational lead and maintain inventories or tracking systems for biospecimen collection, processing, shipment, inventory management, reconciliation, storage, testing, and disposition across clinical studies.
- Develop and maintain study-specific biospecimen management plans, laboratory manuals, collection schedules, handling instructions, collection worksheets, site training materials, and supporting operational documentation.
- Collaborate closely with Clinical Operations to drive biospecimen collection activities, courier coordination, and shipment logistics. Support biospecimen related efforts for site feasibility assessments, investigator meetings, site initiation visits, and site training activities.
- Collaborate with central laboratories, specialty laboratories, biomarker vendors, biorepositories, couriers, and kit providers to ensure timely, compliant, and efficient biospecimen collection, shipment, testing, and inventory management.
- Ensure specimen integrity, chain of custody, traceability, protocol compliance, and inspection readiness throughout the clinical trial lifecycle.
- Partner with Data Management to reconcile biospecimen data against EDC records, source documentation, shipment manifests, laboratory records, and vendor datasets, while identifying and resolving sample discrepancies, documentation gaps, and data quality issues.
- Support implementation of biomarker data transfer standards, data transfer agreements, and data reconciliation processes to ensure traceability of biomarker results to source specimens and study participants.
- Manage sample deviations, shipping excursions, out-of-stability events, missing samples, protocol deviations, and site compliance issues, including root cause investigations and implementation of corrective and preventive actions (CAPAs).
- Lead operational oversight of biomarker laboratories, CROs, and external service providers, including vendor onboarding, contract execution, Statements of Work (SOWs), change orders, performance management, and quality oversight.
- Develop and manage biomarker operations budgets, forecasts, vendor proposals, critical-path timelines, study milestones, and operational deliverables across clinical development programs.
- Ensure compliance with ICH-GCP, FDA and EMA regulations, data privacy requirements, chain-of-custody standards, international shipping requirements, and company SOPs.
- Maintain study documentation in an inspection-ready state and support audits, inspections, quality investigations, and continuous improvement initiatives.
- Serve as a key liaison across Translational Medicine, Clinical Operations, Data Management, Biostatistics, Clinical Development, Regulatory Affairs, Quality, and external vendors to ensure successful execution of biomarker and biospecimen objectives.
- Drive process standardization, operational excellence, and continuous improvement initiatives to enhance efficiency, quality, compliance, and scalability of biomarker operations across the clinical portfolio.
QualificationsRequired- Bachelor's degree in Biology, Life Sciences, Clinical Laboratory Science, Biomedical Sciences, or related field.
- 5+ years of relevant experience for Manager level or 8+ years for Senior Manager level in biotechnology, pharmaceutical, CRO, laboratory operations, or clinical research settings.
- Direct experience managing clinical trial biospecimens and working with biomarker or translational medicine teams.
- Experience setting up and operating central laboratories, specialty testing laboratories, specimen repositories, and external vendors.
- Knowledge of clinical trial regulations, ICH-GCP, and biospecimen operational best practices.
- Strong project management, organizational, problem-solving, written communication, and verbal communication skills.
- Advanced proficiency with Excel and data tracking tools.
Preferred- Experience in late-stage solid tumor oncology clinical development.
- Experience with biomarker assays such as flow cytometry, genomics, proteomics, immune profiling, ctDNA, TCR sequencing, or related technologies.
- Familiarity with ISBER Best Practices, NCI biospecimen guidance, regulatory submissions, or health authority interactions.
