Pioneering Medicines: Associate Director / Director DMPK Project Lead
Core
Lead DMPK strategy and execution for biologics discovery and development, guiding candidate selection and regulatory readiness.
Role type
Associate Director / Director DMPK Project Lead
Builds
Biologics drug candidates (monoclonal antibodies, bispecifics, fusion proteins)
Domain
Biopharmaceuticals / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
DMPK strategy, bioanalysis (BA), immunogenicity science, preclinical study design, regulatory submission authoring, CRO management, toxicokinetic planning, human dose projection
Preferred skills
Small molecules knowledge, novel modalities expertise
Technologies
CRO platforms, regulatory submission systems
Responsibilities
Guide PK, BA, and immunogenicity strategies for cross-functional teams; Design and lead in vitro and in vivo PK/BA/Immunogenicity studies; Interpret data and troubleshoot technical challenges; Collaborate with PK/PD modelers to establish correlations; Contribute to toxicology species selection and toxicokinetic plans; Author DMPK/BA sections of regulatory submissions (INDs, IBs); Develop DMPK functional processes and procedures; Provide operational oversight for quality and performance of DMPK activities; Select and qualify CROs and external vendors.
Seniority
Director level, hands-on IC with strategic oversight
