DMPK and Bioanalytical Associate Director

Key Duties And Responsibilities

• Acts as the DMPK and Bioanalytical Lead on multidisciplinary project teams, representing the integrated DMPK-BA perspective and clearly communicating data, risk assessments, and recommendations to project stakeholders
• Shapes and delivers PK and bioanalytical strategies across a portfolio of biotherapeutic programs, generating high-quality data that directly informs development, translational, and regulatory decision-making from preclinical through clinical stages
• Contributes scientific and strategic input to the design, execution, interpretation, and reporting of in vivo PK and PK/PD studies
• Plans, implements, and manages a broad range of bioanalytical testing activities for biotherapeutic candidates in support of preclinical, clinical and pharmacology studies
• Contributes to bioanalytical method development and phase-appropriate qualification and validation of assays (including ligand binding and cell-based PK, immunogenicity and biomarker assays), and oversees transfer of methods to CROs
• Contributes to CRO evaluation, selection, and ongoing management, including participation in vendor audits, troubleshooting assay performance, and management of external collaborations
• Contributes to preparation of regulatory data packages, dossiers, and responses in support of interactions with health authorities, audits, and inspections
• Reviews and influences changes to systems, procedures, methods, and regulatory submissions to support continuous improvement across bioanalytical and development functions

Knowledge And Skills

• Deep expertise in DMPK and bioanalytical science, with demonstrated ability to integrate in vitro and in vivo data to inform compound progression and risk assessment
• Knowledge of basic pharmacokinetics and experience working with common pharmacokinetics software (e.g., Phoenix WinNonlin)
• Specialized depth of knowledge in bioanalytical assay development for large-molecule therapeutics, including ligand binding and cell-based PK, immunogenicity and biomarker assays
• Strong understanding of phase-appropriate assay qualification and validation and method transfer to external laboratories
• Demonstrated ability to provide scientific and technical leadership on complex, high-value project assignments
• Strong experience working with CROs in regulated environments, including oversight of data quality and compliance with GLP/GxP and relevant regulatory standards
• Working knowledge of quality systems and regulatory requirements (e.g., GLP/GxP, 21 CFR Part 11/210/211)
• Ability to mentor and advise others on technically challenging bioanalytical strategies and execution
• Strong written and verbal communication skills, with the ability to author and review advanced technical documents and effectively communicate scientific concepts to diverse audiences
• Demonstrated initiative, persistence, and scientific creativity to advance development programs
• Values teamwork and collaboration within cross-functional and external partnerships

Education And Experience

• Bachelor’s, Master’s, or PhD in Analytical Chemistry, Biochemistry, Protein Sciences, Chemistry, or a related scientific discipline
• Bachelor's degree (or equivalent degree) and 11+ years of productive, relevant employment experience
• Master's degree (or equivalent degree) and 9+ years of productive, relevant employment experience
• Ph.D. (or equivalent degree) and 6-8+ years of productive, relevant post-doctoral employment experience