Job Summary:
Reporting to the SVP, Research & Early Development, the Associate Director, Biomarker Operations oversees operational aspects of clinical/translational biomarker projects. Leads biomarker operations to support clinical studies by interfacing with the central lab for study start-up, kit preparation/deployment, sample tracking, and vendor contracting/budgets. Partners with Clinical Operations and Translational Science to coordinate communication between the central lab, external CROs, and internal lab personnel. Requires strong communication/project management and understanding of drug development and clinical trial processes.
Duties/Responsibilities:
- Define biomarker operations execution strategy and best practices across clinical trials.
- Lead day-to-day biomarker operations, including vendor execution and ensuring central lab/CRO deliverables and timelines.
- Lead a biomarker operations team supporting current and planned clinical trials.
- Manage biomarker assay documentation/performance, ensure high-quality biomarker data delivery, and support CRO audits.
- Ensure kit preparation and sample testing database builds with required documentation review.
- Coordinate site activation readiness (including training materials).
- Manage collection kit logistics, sample inventory, and discrepancy/missing-information follow-up.
- Coordinate shipping and testing scheduling with central lab and vendors.
- Contribute to data transfer specifications review/implementation.
- Own central lab budget planning and contract oversight; coordinate invoice and contract request timelines with Finance, Procurement, and Legal.
- Lead translational logistics meetings and represent Biomarker Operations at study team meetings.
Requirements:
- Bachelorβs or Masterβs degree in biology, immunology, or related fields and/or project management experience; 6β10 years in biotechnology/pharmaceutical industry.
- Demonstrated experience managing biomarker sample operations for clinical trials with central labs and CROs.
- Strong communication, project management, and interpersonal skills; proactive, flexible, efficient.
- Understanding/experience with drug development and clinical trial processes.
Benefits:
- Medical, Dental, Vision, Group Life Insurance, Long Term Disability (LTD), 401(k), EAP, FSA, PTO, and company-paid holidays.
- Bonus.ly recognition program.
Compensation:
- Base Salary: $175,000β$185,000 (varies by skills/experience).