Manager/Senior Manager, Biomarker & Biospecimen Operations

- Location: Remote

- Salary: $161-$175k

Why Work With Us? 
At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day. 

Our Science: Advancing Cancer Immunotherapies 
Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more:  

Position Summary
Candel 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 sta