Biomarker & Biospecimen Operations Lead (Hybrid)

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

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.