BioAnalytical Manager III
660 East Grand Avenue South San Francisco, CA 94080
Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.
The BioAnalytical Manager (BAM) provides bioanalytical operational expertise to local (PET) and global(SMT) clinical study teams to implement and execute strategies for anti-drug antibody (ADA) and pharmacokinetic (PK) analysis for all phases of clinical studies for Genentech programs. The BAM serves as a single point of contact between scientific functions (BAS, Clinical Pharmacology, DMPK), CROs, and clinical study teams for each clinical study to operationalize sample collection logistics, execute bioanalysis, and facilitate timely delivery of data to internal stakeholders and clinical study teams.
- May work with pharmacology sub-teams to provide input on PK/ADA deliverable timing and to understand clinical program development direction (filings, new studies) to ensure program needs are met.
- Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and CROs.
- Harmonizes sample collection and handling instructions per bioanalytical strategies and assay requirements to ensure they are included in clinical site lab manual. Facilitate resolution of sample and data discrepancies and disposition of samples throughout the study lifecycle.
- Authors and reviews relevant section of study related documents (i.e., central lab SOWs, study protocols/ICFs, bioanalytical reports, etc.).
- Develops study-specific sample and data flows plans with stakeholders (e.g. BAMP). Develops and manages timelines for bioanalytical labs to ensure samples are tested according to protocol and data is transferred in the specified format per study team timelines.
- Assists function with outside spend (PVC) budget planning and management of actual spend (invoices, PO) for studies.
- Contributes to identification of bioanalysis CROs and set up of contracts for bioanalysis, working with internal contacts. Through CRO Central Point of Contact (CPoC), manage CRO deliverables and performance, ensuring all deliverables are met per SOWs and study timelines. Provide inputs on CRO performance, escalating concerns as appropriate.
- May assist with training and participate on organizational initiatives to support business needs.
- Applies relevant regulatory compliance and internal business standards in the performance of job responsibilities (e.g. eTMF, RACT, Maintenance of Study Tracking Documentation).
Education and Experience Requirements:
- Bachelors, M.S., or Ph.D. in biology, chemistry, or related scientific discipline. Project management certification desirable.
- In general, 8 plus years of professional experience in pharmaceutical or biotechnology industry that includes experience related to bioanalysis and sample handling, CRO management, and/or clinical development/operations.
- Working knowledge of ICH GCP.
- Highly effective verbal and written communication.
- Demonstrated ability to influence and collaborate to deliver results in multi-cultural, geographically diverse teams.
- Strong analytical skills to evaluate complex problems for pragmatic solutions.
- Application of independent judgment, with high attention to details.