Associate Director, Biosample Operations
About The Position
Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long-term kidney function. A Phase 1 healthy-volunteer study of JADE101 is ongoing, with interim, biomarker-rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. For more information, visit JadeBiosciences.com and follow us on LinkedIn. The Associate Director, Biosample Operations will oversee all aspects of biosample management strategy, governance, and logistics for Jade’s clinical trial programs. This individual will serve as the bridge between Clinical Operations, Research & Translational Medicine and external partners to ensure high-quality sample collection, processing, tracking, and analysis. The ideal candidate is both strategic and execution-focused, with deep operational expertise and the ability to thrive in a small, dynamic environment. This is an exciting opportunity to make important contributions at Jade by leading and implementing crucial biosample strategies.
Requirements
- Bachelor’s degree + 13 years of related experience, or master’s degree + 10 years of related experience
- 5+ years of experience in clinical trial biosample operations within biotech/pharma or a CRO.
- Strong understanding of clinical trial sample management, including chain of custody, ICH/GCP, biobanking, regulatory expectations and data integration.
- Proven experience managing central lab vendors, biorepositories, and specialty assay providers and implementing operational workflows in a regulated environment.
- Excellent organizational, communication, problem-solving, and cross-functional collaboration skills.
- Proficiency in sample tracking databases/LIMS; experience with EDC integration a plus.
- Ability to work independently in a small-company environment, while thriving in a highly collaborative, cross-functional setting.
- Flexible and nimble to meet the needs and challenges of a growing, dynamic company.
Responsibilities
- Effectively partner with Clinical Operations and Research & Translational Medicine teams to define and implement sample collection, processing and shipment strategies across clinical trials and programs.
- Develop biosample management plans, laboratory manuals and related study documents to ensure alignment of biosample plans with study designs and timelines.
- Support the selection and management of central labs, specialty labs and biorepositories.
- Oversee all aspects of biosample tracking in support of data integrity and ensure alignment with ICH, GCP, GDPR, and any regulatory requirements governing biosample management and human biological materials.
- Serve as the subject matter expert for biosample governance, chain of custody, and regulatory compliance and provide strategic input to program teams and senior leadership.
- Manage biosample vendors including central labs, specialty labs, and biorepositories, ensuring quality, cost, and performance standards are met.
- Oversee collection, processing, storage, and shipment of biological samples (e.g., blood, tissue, PBMCs, CSF) across clinical sites and vendors.
- Act as the primary liaison between Clinical Operations, labs, Data Management and Research & Translational Medicine teams.
- Maintain biosample inventory, resolve discrepancies, contribute to inspection readiness activities and respond to audits or regulatory queries as needed.
- Report biosample related metrics and communicate risks to study teams and leadership and maintain standard processes, tools, and documentation to support efficient biosample operations.
- Troubleshoot biosample related issues with urgency.
- Develop and maintain SOPs, work instructions, and quality standards for biosample handling and documentation.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
11-50 employees
