Job Details

Join to apply for the Director of Biosample Operations role at 89bio

The role reports to the SVP, Clinical Operations and is responsible for the day-to-day management and oversight of biosample collection, processing, storage, and shipment across all global clinical programs. The Director will ensure biosample operations are conducted in compliance with protocol requirements, regulatory standards, and timelines, manage vendor relationships, support internal governance, and serve as a subject matter expert to cross-functional study teams. In addition to core biosample operations, this role will be involved with some clinical site management in the context of biosample collection and compliance at clinical sites.

Responsibilities

• Drive and oversee operational planning and execution of biosample management strategies, and report on status for all clinical studies.
• Define and implement global standards for biosample governance, compliance, documentation, and technology platforms.
• Manage CROs, central labs, and specialty vendors involved in biosample handling, logistics and availability batching and testing timelines, analysis/reanalysis, and data reporting.
• Ensure biosample collection manuals, lab manuals, and associated documentation are accurate, current, and compliant.
• Identify and implement innovative solutions for biosample tracking/reconciliation, digitalization, and operational efficiency.
• Monitor vendor performance and escalate operational risks/issues with mitigation plans.
• Collaborate with Clinical Operations, Clinical Development, Data Management to ensure timely and quality delivery of biosample for analysis.
• Lead interactive data visualizations and analytical tools for reporting metrics and trends and data QC and identify and communicate critical trends to study teams.
• Develop the strategy for scalable sample storage, tracking and access.
• Support sample analysis, data transfer, data reconciliation, and data review.
• Provide study level updates to partners, clinical study teams and biomarker teams including sample collection, assay status and analysis updates.
• Contribute to ICF, protocol, SOP development and continuous process improvement.
• Mentor and provide guidance to matrixed team members.

Qualifications

• Bachelor's degree in life sciences (advanced degree preferred).
• 12 years of industry experience in clinical operations, lab operations, or biosample management with a BA; 8 years with a MA or 5 years with a PhD.
• Proven expertise in vendor oversight/governance, budget oversight, global operations, and inspection readiness.
• Strong organizational and project management skills.
• Ability to influence without authority and work effectively in a matrixed, global environment.

Salary & Level

89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $190,000 – $230,000

89bio's role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law.

The Perks

• Competitive health insurance coverage
• Employee Stock Purchase Plan (ESPP)
• Women's forum / mentoring
• Office based in the heart of San Francisco, near plenty of shops and restaurants
• Fun opportunities to engage with co-workers in-person and remotely

Conditions of Employment

• Background investigations are required for all positions by 89bio, consistent with applicable law.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or disability. 89bio is committed to the full inclusion of all qualified individuals and will provide reasonable accommodations for the hiring process and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.

Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.

Seniority level

• Director

Employment type

• Full-time

Job function

• Product Management, Strategy/Planning, and Research

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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