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Senior Manager, Clinical Biomarker Operations

1 month, 1 week 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 22

Description

  • Plan, track, and manage biomarker sample collection logistics across clinical trials.
  • Oversee sample shipments, vendor testing, sample reconciliation, and final sample disposition.
  • Ensure adherence to clinical study protocols and contribute to biospecimen collection guidance in protocols, ICFs, and lab manuals.
  • Lead finalization of data transfer specifications and support data delivery timeline planning.
  • Maintain sample inventories and coordinate short-term and long-term sample storage solutions.
  • Collaborate closely with Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance.
  • Support review and finalization of MSAs, legal agreements, and other biomarker-related contracts and partnerships.
  • Support QA activities for vendor audits and inspections.
  • Assist with biomarker budget planning, accrual tracking, and financial oversight.
  • Lead vendor selection, vendor performance management, and ongoing vendor oversight to ensure compliance with company standards.
  • Identify and implement process improvements and best practices to improve biomarker operations.
  • Ensure high-quality data generation by protecting sample integrity and coordinating external collaborations.

Requirements

  • MS or higher with more than 3 years of direct experience in biomarker operations, or BS with more than 5 years of direct experience in biomarker operations.
  • Direct experience with biomarker sample management, including logistics, reconciliation, inventory maintenance, collection, and long-term storage.
  • Significant experience with CRO oversight, including contract management, SOW reviews, activity tracking, accrual tracking, and final reconciliation.
  • Experience working across all phases of clinical trials; Phase 3 experience is preferred.
  • Strong understanding of biomarker assays, including flow cytometry, genomics, and protein-based assays, as well as drug development.
  • Excellent communication skills and high emotional intelligence for effective cross-functional collaboration and timeline management.
  • Experience in immunology and inflammation (I&I) indications.
  • Ability to thrive in a fast-paced environment and manage multiple competing priorities under tight timelines.
  • Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.
  • Willingness and ability to travel approximately 4 times per year for All Hands meetings and workshops.

Benefits

  • Anticipated salary range of $150,000 to $170,000 per year.
  • Market-competitive compensation and benefits package, including base salary, performance bonus, and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to resources for continued growth.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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