Biosample Operations Manager, Clinical Operations
Based in Menlo Park, CA since 2018, Zai Lab U.S. is focused on discovering and developing novel therapies for the treatment of cancer and inflammatory diseases. We are an innovative, research-based, commercial stage company, with over 1,600 employees worldwide and a diversified and strong pipeline poised for continued growth. This is an exciting time for us as we build our R&D Drug Discovery team and advance our global pipeline, aiming to produce 1-2 global INDs per year.
The Biosample Operations Manager (BOM) will act as the SME for all biological samples collected during a clinical trial. We are seeking an experienced BOM to support translational and biomarker activities for Zai’s rapidly growing pipeline of small and large molecules in early- through late-stage clinical development. You will be accountable for the execution of the biomarker strategy that includes the planning and coordination of all operational activities required for the collection and delivery of clinical trial samples (Biomarker/CDx, PK, PD, ADA) for assigned studies. The BOM works closely with the Study Team Lead, CRO partners, Site Monitors, Clinical Pharmacology, Translational Medicine, etc. to ensure the study protocol and overall program deliverables are met.
- Drives the implementation and execution of the clinical biomarker and diagnostic plans for clinical programs in early and late-stage clinical development across therapeutic areas.
- Accountable for planning, organizing, and overseeing the collection and shipping of biosamples from Investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality. The BOM will also oversee the assay laboratory, ensure delivery of assay results, and is the primary contact for the assay lab.
- Manage key vendors and CROs to support clinical sample collection, assay laboratory services, sample storage, and/or biomarker analysis including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals.
- Determine timelines and resource needs for all biosample operational activities, ensure these are included in study plans, and are appropriately tracked.
- Write the Study Sample Management Plan to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type.
- Accountable for ensuring that data received is consistent with the collection and assay plans and protocol.
- Provide input to clinical study protocol and ICF to review for collection and analysis rationale, the feasibility of biological sampling, and alignment with Zai Lab policies and study/program plans.
- Utilize operational and project management skills to think through issues to ensure deliverables are met; raise issues to study team lead, translational medicine scientist as needed.
- Maintain oversight of all study biosample operational activities and regularly report on status (including reconciling against consent).
- In coordination with Clinical Operations, provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, presenting sample collection requirements at Investigator Meetings, or training of sites on collection procedures.
- Monitor effectiveness of Investigator site sample handling training and quality of samples received and recommend corrective actions as necessary.
- Ensure study adherence to ICH/GCP and SOPs.
- Identifies areas of best practice and process improvements.
- Life Sciences degree (higher qualification e.g. MSc or Ph.D. preferred).
- 4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
- Competent in the application of standard business procedures (standard operating procedures (SOPs), International Conference on Harmonization (ICH), Global Regulations, Ethics, and Compliance).
- Extensive clinical development experience of working in teams running clinical studies, particularly in oncology and/or immuno-oncology early drug development. Successful track record in oncology employing tissue (e.g., IHC, ISH) as well as genomic biomarker endpoints from tissue and blood samples, including NGS, PBMC-based analysis, FACS, and plasma biomarker analyses.
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
- Critical reasoning skills including the identification and resolution of complex problems.
- Detailed-oriented with the ability to work independently and manage competing priorities.
- Excellent planning, organizational, and time management skills.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Effective communication and presentation skills.
- Proven ability to build and maintain effective working relationships.
Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
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.