(Associate Director) Principal Clinical Pharmacologist, Cell Therapy Discovery
Core
Lead clinical pharmacology strategies for novel cell therapies (CAR-T, mRNA-LNP/lentiviral) by bridging early research and clinical application to optimize dosing and minimize toxicities like CRS.
Role type
Senior IC clinical pharmacologist (cell therapy discovery)
Builds
Clinical study protocols, Investigator's Brochures, Clinical Study Reports, regulatory briefing documents, and PK/PD risk/benefit profiles for cell therapy programs.
Domain
Biopharmaceuticals / Cell Therapy / Clinical Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical pharmacology study design, PK/PD analysis, population modeling, exposure-response simulation, regulatory document authoring, cross-functional team leadership, CRO management, SOP development
Preferred skills
PBPK modeling, flow cytometry data analysis, AI for predictive modeling, drug-drug interaction analysis, cell therapy drug development process familiarity
Technologies
NONMEM, R, WinNonlin, SimCyp
Responsibilities
Lead design and execution of CP studies for IIT/Phase I trials including First-in-Human dose selection; Develop short-to-medium-term CP plans for assets across development stages; Author and finalize core clinical documents (protocols, IB, CSR); Perform advanced PK/PD analyses using non-compartmental methods and population modeling; Synthesize and communicate complex PK/PD results to study teams and senior leadership; Serve as independent CP lead on cross-functional teams; Lead preparation of regulatory briefing documents and represent team with health agencies; Drive establishment of departmental best practices including SOPs and standardized templates
Seniority
Senior, hands-on IC with strategic planning
