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Senior Manager, Clinical Biomarker Operations

59 minutes ago
United States
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 21

Description

  • Plan, track, and manage biomarker sample logistics across clinical trials.
  • Oversee sample shipment, vendor testing, reconciliation, and final sample disposition.
  • Ensure biomarker activities follow the clinical study protocol and support biospecimen collection guidance in protocols, ICFs, and lab manuals.
  • Support finalization of data transfer specifications and sample inventory database setup and maintenance.
  • Help develop biomarker sample inventory strategy and coordinate long-term sample storage and external sample shipments.
  • Support biomarker quality assurance activities, including gap analyses for inspection readiness.
  • Coordinate review and finalization of MSAs, legal agreements, contracts, and related partnership documents.
  • Work closely with Biomarker Scientists, Data Management, Clinical Operations, Finance, Procurement, and Quality Assurance teams.
  • Support biomarker budget planning and accrual tracking.
  • Lead vendor selection, performance management, and oversight to ensure compliance with company standards.
  • Identify and implement process improvements and best practices.

Requirements

  • MS or higher with more than 3 years of direct experience in a biomarker operations role, or BS with more than 5 years of direct experience.
  • Demonstrated experience managing biomarker samples, including logistics, reconciliation, and inventory maintenance from collection through long-term storage.
  • Significant experience with CRO oversight, including contract management, SOW reviews, activity tracking, accrual tracking, and final reconciliation.
  • Experience working in all phases of clinical trials.
  • Strong understanding of biomarker assays, including flow cytometry, genomics, and protein-based assays, and of drug development more broadly.
  • Excellent communication skills and high emotional intelligence for effective cross-functional collaboration and timeline management.
  • Ability to work in a fast-paced environment, manage multiple competing priorities, and remain flexible under tight timelines.
  • Willingness and ability to travel at least about 4 times per year for All Hands meetings and workshops.
  • Experience in biomarker QA, inspection readiness, or departmental process gap analysis is preferred.
  • Familiarity with Apogee’s C.O.R.E. values and a collaborative, low-ego work style is preferred.

Benefits

  • Anticipated base salary of $150,000-$170,000 per year.
  • Market-competitive compensation and benefits package.
  • Performance bonus opportunities.
  • Equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, plus two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to growth resources.

Interested in this position?

Apply directly on the company website

Apply Now

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