Director, Translational Operations (Biotech)

TL;DR

Director, Translational Operations (Biotech): Leading biospecimen operations across clinical programs to ensure high-quality biomarker and translational data with an accent on operationalizing sample workflows and vendor oversight. Focus on building scalable, inspection-ready biospecimen lifecycles and managing complex global logistics for cell therapy trials.

Location: Hybrid in South San Francisco, CA (US-based remote may be considered)

Salary: $200,000 - $230,000 per year

Company

hirify.global is a clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Own the end-to-end biospecimen operational strategy for clinical studies from protocol design through database lock and long-term storage.
• Lead internal teams and external vendors responsible for biospecimen collection, kitting, shipping, receipt, and analysis.
• Develop sample lifecycle process maps and integrate biospecimen requirements into protocols, lab manuals, and operational plans.
• Establish and monitor KPIs/KQIs for collection compliance, shipment timeliness, sample integrity, and assay turnaround time.
• Manage chain-of-custody, labeling standards, reconciliation, deviations, and CAPA processes for biospecimens.
• Oversee budgets, forecasts, and vendor governance to ensure delivery according to SOWs, quality expectations, and timelines.

Requirements

• Bachelor’s degree in life sciences, bioengineering, clinical research, or a related field (advanced degree preferred).
• At least 10 years of industry experience in translational or clinical sample operations, with at least 5 years in a leadership role.
• Expertise in building biospecimen workflows for multi-site clinical trials, including cold-chain shipping and biorepository operations.
• Strong knowledge of clinical research operations and GxP/GCLP principles.
• Must be authorized to work in the U.S.
• Willingness and ability to travel domestically and internationally as required.

Nice to have

• Experience in cell therapy and/or oncology clinical trials.
• Experience with global sample operations, including ex-US shipping and import/export documentation.
• Familiarity with LIMS and operationalizing biomarker data transfers into clinical databases.
• Experience partnering with Quality on vendor audits, quality agreements, and QMS expectations.

Culture & Benefits

• Collaborative environment working with highly talented people.
• Comprehensive compensation package including annual performance bonus and equity.
• Full health insurance coverage.
• Generous time off, including two annual company-wide holiday shutdowns.