Principal Scientist, Clinical Pharmacology
Core
Lead clinical pharmacology strategy for antibody-based therapies from first-in-human through late-stage development, optimizing trial designs and dose selections using Model-Informed Drug Development (MIDD) approaches.
Role type
Principal Scientist, Clinical Pharmacology (Strategy & Modeling)
Builds
Clinical trial designs, dosing regimens, and regulatory submissions for novel antibody therapies
Domain
Biotechnology / Clinical Pharmacology / Pharmacometrics
Required skills
Clinical pharmacology strategy, Model-Informed Drug Development (MIDD), Population PK/PD modeling, PBPK, QSP, Regulatory submission writing, CRO management, Therapeutic antibody development, Exposure-response analysis, Dose selection, Biomarker integration
Preferred skills
Experience with NONMEM, Monolix, R, Target-mediated drug disposition, Immunogenicity assessment, Special populations studies, Health authority interactions
Technologies
NONMEM, Monolix, R, PBPK, QSP
Responsibilities
Lead clinical pharmacology strategy for therapeutic programs, Apply MIDD to justify doses and optimize study designs, Recommend first-in-human starting doses, Build integrated clinical pharmacology plans, Execute pharmacometric methodologies, Design clinical pharmacology trial components, Write regulatory documents and briefing materials, Prepare for health authority meetings, Manage CROs and modeling service providers, Present results to leadership
Seniority
Principal, Strategy & Mentorship