Job Description

The Director/Sr Director of Bioanalytical Sciences (BA) will lead BA activities and develop bioanalytical strategies for the projects they support. This role will create and drive bioanalytical development plans and collaborate with project teams and governance bodies. Lead and build positive relationships to create an environment to constantly ensure compliance with internal procedures and processes, set up a development BA function and with guided by documents from the FDA, EMA and other regulatory agencies. Develop strategies, interact with regulatory agencies for specific issues on bioanalytical methods and is accountable for provision of the bioanalytical portions of IND, NDA/BLA/MAA, IB CSRs and other regulated documents including devising strategies for Regulatory interactions as needed.
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.

Qualifications:
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.

Job Tags

Contract work, Work experience placement,

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