Apply on Employer Site

Jade Biosciences · 7 hours ago

Associate Director, Biosample Operations

San Francisco, CA

Part-time

Hybrid

Lead/Staff, Director/Executive

$170K/yr - $190K/yr

10+ years exp

Jade Biosciences is focused on developing innovative therapies for autoimmune diseases. The Associate Director, Biosample Operations will oversee biosample management strategy and logistics for clinical trial programs, ensuring high-quality sample collection and compliance with regulatory standards.

Health CareTherapeutics

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

Qualification

Biosample operationsClinical trial managementRegulatory complianceSample tracking databasesVendor managementCommunication skillsProblem-solving skillsOrganizational skillsCross-functional collaboration

Required

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