Associate Director, Bioanalytical Development

Responsibilities

• Lead bioanalytical strategy and delivery for assigned programs across small molecules and biologics, aligned to clinical questions and decision points
• Define assay plans and validation approaches (fit-for-purpose through full validation) for PK/TK, metabolites as applicable, biologics bioanalysis, and immunogenicity
• Manage bioanalytical CROs and specialty labs for assigned workstreams: contribute to partner selection, define scopes, set timelines, and monitor performance, quality, and budget
• Oversee end-to-end bioanalytical execution: protocols, validation reports, sample analysis, data review, and final reports to support program decisions and filings
• Own day-to-day BA operating processes for assigned programs: assay lifecycle tracking, method transfer planning, issue triage, deviation management, and CAPA follow-up with vendors
• Ensure data quality and audit readiness for assigned deliverables through strong documentation practices, traceability, and alignment to regulatory guidance and internal standards
• Partner with Clinical Pharmacology and Clinical Development on study design inputs, sampling strategies, analyte panels, and interpretation of exposure and immunogenicity implications
• Coordinate with Clinical Operations on sample logistics (kits, handling, stability, chain of custody, reconciliation) and resolution of operational issues impacting bioanalysis
• Collaborate with Regulatory Affairs by drafting/reviewing submission components and providing technical input to support IND/CTA and NDA/BLA/MAA activities
• Align with DMPK/Nonclinical on bioanalytical approaches across studies and support translational PK needs
• Work with Biostatistics/Data Science to enable clean data transfers, consistent formats/metadata, and analysis-ready datasets
• Support diligence and asset evaluation by reviewing bioanalytical packages, identifying gaps/risks, and proposing pragmatic remediation plans
• Contribute to Trial Engine scaling by helping standardize templates, workflows, and reporting conventions that improve speed and consistency across programs

About You

Compensation Range

• $167,000 - $230,000
• Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.
• You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.