Associate Director, Bioanalytics
Vir Biotechnology (Vir), a San Francisco based company focused on infectious diseases seeks an Associate Director of Bioanalytics who will be responsible for developing bioanalytical methods to support development of small and large molecule assets. You will oversee the development, execution, and reporting of bioanalytical analyses, including contribution to regulatory documents, and will work cross functionally to ensure reliable data are provided to end-users in accordance GxP requirements. Additionally, you will be responsible for selection and management of external vendors, participate in vendor audits, and manage all aspects of method development, validation, study sample analysis and reporting of data.
- Develop bioanalytical methods to support small and large molecule clinical candidates and providing bioanalytical input across all functional areas and stages of research and development.
- Plan bioanalysis strategy, which may entail internal and/or external analysis, including vendor selection and management.
- Coordinate method development and analysis activities within the context of development plans.
- Ensures the delivery of high quality quantitative, biomarker, and immunogenicity data to relevant teams from data generated by internal and contract labs.
- Performs troubleshooting and evaluation of a variety of complex methods to identify appropriate bioanalytical solutions.
- Conducts on-site visits to CROs to review core capabilities and lab processes to ensure GLP compliance and assay data quality. Evaluation and assessment of capabilities of new CROs.
- Functions as a consultant in areas of expertise across all parts of the organization.
- Projecting and managing budgets associated with bioanalytical activities.
- Leading technology transfer of bioanalytical methods, as appropriate.
- Independently produces well written and accurate technical summaries and reports complying with scientific, business, and regulatory needs.
- Interacting with internal Research, CMC, Operational, and Regulatory groups to support drug development activities.
- Review and approval of data and reports from external vendors.
- Contributes to drafting of sample collection manuals, clinical scope-of-work documents, and pharmacy manuals, as appropriate.
- Train Clinical Operations colleagues and clinic site staff to support sample, material, and processing needs.
- Ensuring appropriate records are maintained detailing sample/shipping conditions and chain of custody.
- Growing and training Bioanalytical team in alignment with company goals.
- Contribute to the strategy and analysis of exploratory biomarkers.
QUALIFICATIONS AND EXPERIENCE:
- Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation for clinical and non-clinical studies.
- Demonstrated expertise in GLP and GCP compliance of sample handling and storage, bioanalytical assay development, sample analysis, and laboratory operation and procedures/processes is required.
- Technical expertise with a wide variety of platforms to analyze all aspects of small and large molecule therapeutics, including those with complex sample handling and preparation procedures (e.g., enzymatic assays, ligand-binding assays, cell-based assays, etc.) from a variety of biological matrices (e.g., serum, plasma).
- Familiar with PK and PD principles pertaining to establishment of relevant assays and assay ranges.
- Strong written and verbal communication skills, able to articulate complex concepts to internal and external team members and contribute to authoring reports, SOPs, regulatory filings, or other relevant documents.
- Ability to work in a high-paced team environment, meet deadlines, and prioritize work from multiple programs.
- Demonstrated excellence in people and project management.
- PhD (+ at least 8 years) or BS/MS (+ at least 15 years) in a relevant scientific field with corresponding industrial experience.