Manager/Senior Manager, Biomarker & Biospecimen Operations

Scorpion Therapeutics; United States; Remote; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Job summary

Scorpion Therapeutics seeks a Senior Manager/Manager, Biomarker & Biospecimen Operations to lead biospecimen collection, handling, inventory, and documentation. You will develop operational plans and collaborate with Clinical Ops, Translational Medicine, and vendors to ensure specimen integrity and inspection readiness.

The role emphasizes regulatory compliance (ICH-GCP, FDA, EMA), data reconciliation, and process standardization to support biomarker programs in oncology.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years (Manager) or 8+ years (Senior Manager) in clinical trial biospecimen management.
• Experience in biomarker sample handling, laboratory operations, and regulatory standards.
• Preferred: experience in late-stage solid tumor oncology and biomarker assay technologies.

Responsibilities

• Managing biospecimen collection, shipment, inventory, and documentation.
• Developing operational plans.
• Collaborating with Clinical Operations, vendors, and internal teams to ensure specimen integrity, compliance, and inspection readiness.
• Reconciling data and resolving discrepancies.
• Overseeing external vendors and laboratories.
• Ensuring adherence to regulations like ICH-GCP, FDA, and EMA.

Skills

Biospecimen management

Clinical operations

Regulatory compliance

Data reconciliation

Vendor management

Education

Bachelor's in Life Sciences

Tools

Flow cytometry

Genomics

Proteomics

Job description

Senior Manager/Manager, Biomarker & Biospecimen Operations

Responsibilities include

• managing biospecimen collection, shipment, inventory, and documentation;
• developing operational plans;
• collaborating with Clinical Operations, vendors, and internal teams to ensure specimen integrity, compliance, and inspection readiness;
• reconciling data and resolving discrepancies;
• overseeing external vendors and laboratories;
• ensuring adherence to regulations like ICH-GCP, FDA, and EMA.

The role involves cross-functional collaboration with Translational Medicine, Clinical Ops, Data Management, and external vendors, with a focus on process standardization, operational excellence, and compliance.

Qualifications

• Bachelor's in Life Sciences or related field;
• 5+ years (Manager) or 8+ years (Senior Manager) in clinical trial biospecimen management, with experience in biomarker sample handling, laboratory operations, and regulatory standards.
• Preferred: experience in late-stage solid tumor oncology, biomarker assay technologies (flow cytometry, genomics, proteomics), and familiarity with biospecimen guidance and regulatory submissions.

Location: Remote; no sponsorship required.