Associate Director, Bioanalytical Development
Core
Lead bioanalytical strategy and delivery for assigned preclinical and clinical programs across small molecules and biologics, ensuring assays are fit for purpose and support key development decisions.
Role type
Associate Director, Bioanalytical Development
Builds
PK/TK, metabolites, biologics bioanalysis, and immunogenicity assays for clinical and nonclinical programs
Domain
Biopharmaceuticals, Bioanalysis, Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LC–MS/MS expertise, assay validation strategy, CRO/vendor management, regulatory documentation, data quality assurance, cross-functional collaboration
Preferred skills
Clinical study team integration, GCP/GCLP audit readiness, sample logistics management
Technologies
LC–MS/MS, bioanalytical software platforms
Responsibilities
Define assay plans and validation approaches for PK/TK, metabolites, biologics, and immunogenicity; Manage bioanalytical CROs and specialty labs for assigned workstreams; Oversee end-to-end bioanalytical execution including protocols, validation reports, and data review; Partner with Clinical Pharmacology and Clinical Development on study design and sampling strategies; Collaborate with Regulatory Affairs on submission components for IND/CTA and NDA/BLA/MAA activities; Support diligence and asset evaluation by reviewing bioanalytical packages
Seniority
Senior, hands-on IC with strategic oversight
