Principal Scientist, Clinical Pharmacology

AbCellera•California, CA

About The Position

AbCellera is seeking an experienced clinical pharmacology scientist to shape the dosing, study, and development of antibody-based therapies from first-in-human studies through late-stage development. The role leads clinical pharmacology strategy for therapeutic programs and applies Model-Informed Drug Development (MIDD) to optimize clinical trial designs, justify dose selections, inform development decisions, and mitigate risks across early- and late-stage development. The Principal Scientist serves as the clinical pharmacology representative on cross-functional program teams and in interactions with health authorities. The position works closely with Pharmacokinetics, Biomarkers, Clinical Development, Biometrics, and Regulatory Affairs teams. It also contributes to the development of AbCellera’s clinical pharmacology function, including its processes and standards.

Requirements

PhD or PharmD in Pharmacology, Pharmaceutical Sciences, Pharmacometrics, or a related quantitative discipline, with 8 or more years of clinical pharmacology experience in the biotech or pharmaceutical industry; alternatively, an MSc with 12 or more years of clinical pharmacology experience.
Experience leading clinical pharmacology for therapeutic antibodies or other biologics, with understanding of target-mediated drug disposition, immunogenicity, and drug absorption kinetics.
Extensive hands-on experience with population PK and PK/PD, exposure-response modeling, pharmacometrics tools such as NONMEM, Monolix, or R, and methodologies such as PBPK and QSP; ability to critically review modeling work by others.
Experience contributing clinical pharmacology content to regulatory submissions and health authority interactions, such as FDA, EMA, or Health Canada.
Experience managing CROs or external modeling service providers.
Experience incorporating Modeling & Simulations outcomes into regulatory documents, including Investigator Brochures, briefing books, and IND filings.
Ability to thrive in a dynamic working environment and support and work with cross-functional teams.
Ability to express complex ideas understandably and communicate effectively with people from different fields.
Excellent documentation skills and impeccable attention to detail.

Responsibilities

Lead clinical pharmacology strategy for assigned therapeutic programs from first-in-human through Phase 2 and into late-stage planning.
Apply MIDD approaches to justify doses and dosing intervals, optimize study designs, and support go/no-go decisions.
Recommend first-in-human starting doses and escalation schemes by integrating nonclinical PK/PD, toxicology, target engagement, and translational biomarker data.
Build integrated clinical pharmacology plans addressing PK, PD, exposure-response, dose and regimen selection, immunogenicity, intrinsic and extrinsic factors, and formulation or route changes.
Execute pharmacometric methodologies, including population PK/PD, PBPK, and QSP, to understand exposure-response relationships and define quantitative criteria for data-driven decisions.
Design and interpret clinical pharmacology components of trials, including dose escalation, bioavailability and absorption kinetics, target-mediated drug disposition, special populations, and bridging studies.
Write and review clinical pharmacology content for protocols, Investigator Brochures, clinical study reports, briefing documents, CTAs, INDs, and other documents supporting regulatory interactions.
Prepare for health authority meetings and draft responses to clinical pharmacology questions.
Manage CROs and modeling service providers to deliver high-quality analyses on time.
Present results and recommendations to program teams and senior leadership.
Help shape AbCellera’s clinical pharmacology function, including its processes and standards.