Manager/Senior Manager, Biomarker & Biospecimen Operations

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Candel Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1999

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Candel Therapeutics is a clinical-stage biotechnology company developing off-the-shelf engineered viral immunotherapies for solid tumors. The company advances two genetically modified viral platforms: aglatimagene besadenovec (CAN-2409), an intratumoral adenoviral gene therapy encoding HSV-thymidine kinase used with oral prodrugs to induce immunogenic cell death and CD8+ T cell–mediated anti-tumor immunity; and linoserpaturev (CAN-3110), a replication-competent, Nestin-promoter–controlled oncolytic HSV designed for tumor-specific killing (notably high-grade glioma). Candel reports Phase 3 data for aglatimagene in prostate cancer with strong pathological response rates and has received FDA Fast Track and RMAT designations; it positions itself as an immuno-oncology company focused on improving outcomes and preserving quality of life.

📋 Description

• Oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical development programs • Serve as operational lead for biospecimen inventories and tracking systems across clinical studies • Develop and maintain study-specific biospecimen management plans, laboratory manuals, schedules, handling instructions, worksheets, training materials, and operational documentation • Collaborate with Clinical Operations on biospecimen collection, courier coordination, shipment logistics, feasibility assessments, investigator meetings, site initiation visits, and site training • Coordinate with central laboratories, specialty laboratories, biomarker vendors, biorepositories, couriers, and kit providers • Ensure specimen integrity, chain of custody, traceability, protocol compliance, and inspection readiness • Reconcile biospecimen data with EDC records, source documentation, shipment manifests, laboratory records, and vendor datasets • Support biomarker data transfer standards, data transfer agreements, and data reconciliation processes • Manage sample deviations, shipping excursions, out-of-stability events, missing samples, protocol deviations, and site compliance issues, including root cause investigations and CAPAs • Provide operational oversight of biomarker laboratories, CROs, and external service providers, including onboarding, contracts, SOWs, change orders, performance management, and quality oversight • Develop and manage budgets, forecasts, vendor proposals, critical-path timelines, study milestones, and operational deliverables • Ensure compliance with ICH-GCP, FDA and EMA regulations, data privacy requirements, chain-of-custody standards, international shipping requirements, and company SOPs • Maintain inspection-ready study documentation and support audits, inspections, quality investigations, and continuous improvement • Liaise across Translational Medicine, Clinical Operations, Data Management, Biostatistics, Clinical Development, Regulatory Affairs, Quality, and external vendors • Drive process standardization, operational excellence, and continuous improvement across biomarker operations

🎯 Requirements

• 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 • All applicants must be authorized to work in the US and must not require sponsorship • Preferred: Experience in late-stage solid tumor oncology clinical development • Preferred: Experience with biomarker assays such as flow cytometry, genomics, proteomics, immune profiling, ctDNA, TCR sequencing, or related technologies • Preferred: Familiarity with ISBER Best Practices, NCI biospecimen guidance, regulatory submissions, or health authority interactions

🏖️ Benefits

• Supportive, mission-driven environment • Transparent and empowering leadership • Flexible culture • Trust, flexibility, and accountability • SMS/text message updates regarding job application status, interview invitations, reminders, and related information