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Director/Sr Director of Bioanalytical Sciences - Consultant
561 Eccles Avenue South San Francisco, CA 94080 US
Job Description
In addition, the incumbent will also be responsible for providing input in the development of bioanalytical protocols, ensuring successful input into the design of assays to support the studies and scientific review and approval of work by CROs and consultants. The incumbent will collaborate with departments including Clinical Pharmacology, DMPK, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Project Management, Toxicology, and Discovery Research for the design and execution of bioanalytical components (PK, PD, biomarkers, etc) of studies. The incumbent participates in various teams including study teams and project teams to support large and small molecule therapeutics at various stages of discovery/development.
RESPONSIBILITIES:
- Responsible for development and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of candidate large and small molecules, metabolites, and biomarkers, to support a diverse portfolio of candidate molecules in clinical studies
- Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing data/method transfer between CROs
- Author, review and interpret bioanalytic data and reports
- Determine additional bioanalytical requirements if needed and perform regular site visits and inspections to ensure regulatory compliance
- Responsible for high quality reports for regulatory submissions (such as INDs or Common Technical Documents) as well as for implementation of a strong quality and compliance program for all bioanalytical work, including compliance with GxP regulations for non-clinical safety and clinical studies
- Drive continuous innovation and change internally and externally and closely collaborate internally with Clinical Pharmacology, DMPK, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Project Management, Toxicology, and Discovery Research groups to align on strategy and tactics
- Build a bioanalytical strategy and development plan for therapeutics at various stages of clinical development
- Build an environment of inclusion, compliance, continual improvement and high efficiency
- Lead the Bioanalytical function and develop SOPs that guide the regulated bioanalytical laboratory operations
- Manage compliance of all regulated bioanalytical laboratory operations, to support development activities, with good laboratory practices (GLP), OECD regulations, FDA, EMA, PMDA and other relevant global bioanalytical guidance documents
- Support clinical innovations by developing and qualifying/validating bioanalytical assays as appropriate
- Serve as the BA Project Lead for exciting projects in the pipeline requiring input from a highly experienced bioanalytical scientist on PK, PD and biomarker assays. Own the interpretation of bioanalytical data provided to project teams and governance bodies.
- Responsible for the preparation of clinical study protocols, reports and the BA sections of IND, IMPD, NDA, EOP2 meetings and other regulatory documents.
An advanced degree in Analytical chemistry with (10+ years) of experience. Well versed in modern bioanalytical techniques, various Immunoassays/platforms (ADA assays, ELISA and platform based assays such as MSD/GYROS ) and other allied bioanalytical techniques such as LC/MS-MS methodologies. Documented work experience in a regulated bioanalytical environment supporting clinical programs. Experience in small company setting.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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