Bioassay Development, Qualification/Validation SME Bioassay development consultants will be required to evaluate or develop bioassay development plans and recommend strategies and experiments to optimize assays and/or qualify/validate the assays, for use in a clinical and nonclinical studies. Bioassay consultants may be asked to assist in the establishment of milestones related to assay optimization or validation. Bioassays may be used to measure drug product in manufacturing studies, and/or in serum or tissue samples obtained from clinical and/or nonclinical studies. The NIH may seek guidance from consultants on the design and interpretation of commonly used in vitro assays, such as biochemical and/or cell-based assays. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects. Bioassay-related consultation services may be required on an ad hoc basis or through LDTs. Bioassay SME Consultants will: 1) Provide expertise in developing, qualifying/validating assays required to support PK/PD, toxicology, and clinical safety studies, and manufacturing/release testing of the biologic 2) Assist in the establishment of milestones related to assay optimization or validation 3) Serve as the assay development expert in order to identify potential developmental challenges and suggest strategies to address these challenges on realistic timelines 4) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage programs to facilitate lead optimization, IND enabling, and clinical studies execution 5) Serve as a resource to lead development team members for assay requirements, and logistics to conduct biologics development activities from the preclinical stage through to the initial clinical stage 6) Collaborate on the design of investigative studies in support of biologics development. 7) Serve as a resource to LDT for assay requirements and logistics to conduct biologics development activities from the preclinical stage through to the initial clinical stage The role of the Bioassay SME consultant may include, but is not limited to, the following responsibilities and tasks: a) Review and comment on the adequacy of bioassay approaches proposed by Principal Investigators (PIs) and/or CMOs/CORs b) Evaluate bioassay development and/or qualification/validation studies on a weekly or biweekly basis c) Serve as the team bioassay expert in order to identify potential product development challenges and suggest strategies to address these challenges d) Collaborate on design of studies in support of therapeutics development projects e) In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage bioassay studies to facilitate preclinical evaluation and safety testing, Investigational New Drug (IND) submissions, and clinical studies f) Facilitate LDT discussions via telephone and email regarding assigned ...