The Head of Bioanalytical Development will provide leadership in design, development, and oversight of PK, PD and immunogenicity bioanalysis assessments, in support of pre-clinical and clinical development programs, and regulatory development for products from nonclinical development to filing NDA. This role reports into the Vice President of Clinical Pharmacology.
Duties and Responsibilities:
Lead the development of a plan/strategy for pre-clinical and clinical PK, PD (biomarkers) and ADA bioanalysis;
Execute the pre-clinical and clinical PK, PD. and immunogenicity bioanalytical; immunogenicity strategies in collaboration with CRO’s;
Interact with a cross functional team in Clinical Development, Clinical Pharmacology, Discovery and Toxicology colleagues;
Planning, preparing and reviewing drug development plans with a focus on PK, biomarker and immunogenicity bioanalytical assessments for nonclinical and clinical development projects. This includes assisting with the determining scope, design, planning and analysis of nonclinical development, clinical pharmacology and clinical development studies. Responsibilities include describing results of validation reports and sample analysis reports in various regulatory documents (IND’s, End of Phase II meeting, pre-NDA, NDA’s, IB’s, etc.).
Leading assay development for PK, PD and immunogenicity (ADA, Nab, cross-reactivity to relevant endogenous compounds);
Leading assay validation for PK, PD and immunogenicity (ADA, Nab, cross-reactivity to relevant endogenous compounds);
Represent Intarcia in interactions with regulatory agencies and respond to regulatory inquires related to PK, biomarker and immunogenicity assessments; and,
Participate in the evaluation of potential in-licensing candidates. Serve as early development sciences expert representative on teams evaluating candidates for in-licensing or risk sharing opportunities.
Ability to work effectively independently and in multi-disciplinary teams, with peers, and with senior management to move projects forward;
Experience interacting with regulatory agencies including being directly involved in the review process;
Must have been directly involved with successful major regulatory filings;
Preferably have had hands on experience preparing and writing regulatory documents from IND through NDA, specifically 2.7.1 and 2.7.2;
Proven ability to manage CROs and consultants;
Excellent written and oral communication skills;
Ability to think critically and solve problems;
Ability to navigate and be successful in a fast-paced, highly-matrixed work environment; and,
Embody and model Intarcia’s core values.
Required/Preferred Education and Licenses
This position requires an MS or Ph.D. in biochemistry, chemistry, or a related science and 10 or more years of related experience developing/troubleshooting, method validation, and analysis of study samples for PK and immunogenicity bioanalytical assays in a regulatory environment in the pharmaceutical or biotechnology industry.