Senior Manager, Clinical Laboratory Operations

Scorpion Therapeutics; Waltham (MA); On-site; USD 135,000 - 168,000; Full time

Benefits offered by this job

Competitive compensation

Equity

Full benefits

Job summary

Scorpion Therapeutics seeks a Senior Manager, Clinical Laboratory Operations to lead operational execution of lab sample handling across clinical development programs.

You will partner with Translational Sciences, Clinical Development, Clinical Operations, Data Management, QA, Procurement, and CROs to ensure compliant, high-quality lab data generation from collection to final disposition.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 6+ years of clinical sample management or lab operations.
• Knowledge of collection/shipping, data transfers, and sample storage.
• Experience with CROs/central labs and sample storage vendors.
• Familiarity with GCP, ICH, consent requirements, and data privacy.
• Ability to manage multiple studies in a fast-paced, matrixed environment.

Responsibilities

• Plan and manage biomarker and central lab sample logistics and testing.
• Lead lab operations for assigned study teams and develop documentation.
• Oversee external labs, CROs, and vendor contracts and budgets.
• Coordinate data transfer specs and final deliverables.
• Support inspection readiness and risk mitigation efforts.
• Drive continuous improvement of lab ops processes and vendor oversight.

Skills

Lab operations

Vendor management

Biomarker logistics

Cross-functional collaboration

GCP/ICH knowledge

Regulatory compliance

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Position Summary

Senior Manager, Clinical Laboratory Operations will lead the operational execution of laboratory sample collection, tracking, testing, reconciliation, data transfer, and final sample disposition across Zenas’ clinical development programs. Partner with Translational Sciences, Clinical Development, Clinical Operations, Data Management, Quality Assurance, Procurement, Legal, Finance, CROs, central laboratories, and specialty biomarker vendors to ensure high-quality, compliant, efficient lab data generation.

Key Responsibilities

• Plan and manage biomarker, bioanalytical and central lab sample logistics (kits/supplies, collection, processing, shipment, testing, reconciliation, storage, inventory tracking, chain of custody, use tracking, final disposition).
• Serve as laboratory operations lead for assigned study teams; contribute to protocols, informed consent forms, laboratory manuals, sample collection schedules, sample management plans, collection guidance, inventory tracking processes, and data delivery timelines.
• Oversee/manage external labs, CROs, central labs, specialty testing vendors, and sample storage vendors (qualification, onboarding, performance management, issue resolution, SOWs, budgets, contracts, capabilities, risks, and adherence to scope/timelines).
• Coordinate data transfer specifications and sample reconciliation outputs; manage testing status updates and final deliverables.
• Support inspection readiness and quality improvements by maintaining complete/current documentation and identifying/escalating/resolving lab handling/testing/reporting risks and bottlenecks.
• Drive continuous improvement of lab sample operations processes, templates, vendor oversight practices, sample management systems, and scalable biomarker operations infrastructure.

Qualifications

• Bachelor’s degree in life sciences, clinical research, laboratory sciences, or related; advanced degree preferred.
• 6+ years of clinical sample management experience.
• Knowledge of sample collection/processing/shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long-term storage.
• Experience managing CROs/central labs/specialty biomarker labs and sample storage vendors.
• Experience with global clinical trials and cross-functional work.
• Familiarity with GCP, ICH, informed consent requirements, chain of custody, data privacy, and inspection readiness.
• Ability to manage multiple studies/vendors/priorities/budgets/timelines in a matrixed, fast-paced environment.
• Strong communication, collaboration, problem-solving, and organizational skills; ability to influence stakeholders and drive resolution.

Benefits

• Competitive compensation and benefits package; base salary range: $134,500–$168,228; total rewards include annual performance bonus, equity, full benefits, and other incentives.