Director of Biosample Operations

THE COMPANY
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-
in-class therapies for patients with liver and cardiometabolic diseases who lack optimal
treatment options. The company is focused on rapidly advancing its lead candidate,
pegozafermin, through Phase 3 clinical development for the treatment of metabolic
dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor
21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity
through an extended half-life. The company is headquartered in San Francisco.

SPECIAL ADVISORY
The FTC has an advisory out on the domain 89biocareers.com if you are contacted by any
group using a similar, but not our exact domain 89bio.com, please Report any Scams.

THE ROLE
Reporting to the SVP, Clinical Operations, the Director of Biosample Operations will be
responsible for the day-to-day management and oversight of biosample collection,
processing, storage, and shipment across all global clinical programs. This role ensures
biosample operations are conducted in compliance with protocol requirements, regulatory
standards, and timelines. The Director will 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.

THE 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.

THE 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.
• Occasional travel required.

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
• Generous PTO allowance
• 401k match
• Employee Stock Purchase Plan (ESPP)
• Commuter Benefits
• 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 based on
disability.
89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bio will
ensure that persons with disabilities are provided 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.