Manager/Senior Manager, Biomarker & Biospecimen Operations

Candel Therapeutics, Inc.; Needham, Northern (MA, KY); Hybrid; USD 161,000 - 175,000; Full time

Job summary

Candel Therapeutics, Inc. is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations in Needham, MA. You will oversee biospecimen collection, tracking, shipment, and vendor management across clinical programs, ensuring quality, compliance, and inspection readiness.

Collaborating with Translational Medicine, Clinical Operations, Data Management, and external partners, you will drive process improvements, SOPs, and budget planning to support biomarker initiatives across trials.

Qualifications

• Bachelor’s degree in Biology or related field.
• 5+ years of relevant experience for Manager level or 8+ years for Senior Manager level.
• Direct experience handling biospecimens and biomarker teams.
• Experience setting up central/specialty labs and working with external vendors.
• Knowledge of ICH-GCP and biospecimen regulations.
• Strong project management and communication skills.
• Advanced proficiency with Excel and data tracking tools.

Responsibilities

• Serve as operational lead and manage biospecimen inventories and tracking across studies.
• Develop and maintain biospecimen management plans and related documentation.
• Coordinate with Clinical Operations for collection, courier, and shipping logistics.
• Collaborate with labs, biomarker vendors, and couriers to ensure timely collection and testing.
• Ensure specimen integrity and chain of custody throughout trials.
• Reconcile biospecimen data with EDC records and vendor datasets.
• Support biomarker data transfer standards and data reconciliation.
• Manage deviations, CAPAs, and site compliance issues.
• Oversee biomarker labs, CROs, and vendor relationships.
• Develop budgets, forecasts, and study timelines for biomarker operations.
• Ensure compliance with ICH-GCP, FDA/EMA, and privacy regulations.
• Maintain inspection-ready study documentation and support audits.
• Coordinate with multiple departments to ensure successful biomarker objectives.
• Drive standardization and continuous improvement in operations.

Skills

Project management

Communication skills

Data tracking

Problem solving

Written communication

Verbal communication

Excel

Education

Bachelor’s degree in Biology or related field

5+ years of relevant experience

8+ years for Senior Manager level

Job description

• Location:Needham, MA (Hybrid office schedule)
• Salary: $161-$175k

Why WorkWithUs?

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’san exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com

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 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.

Qualifications

Required

• 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.

NOTE: All applicants must be authorized to work in the US and do not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time