Principal Scientist, Clinical Pharmacology

We are seeking an experienced scientist with expertise in Clinical Pharmacology who can help shape how AbCellera's antibody-based therapies are dosed, studied and developed, from first-in-human through late-stage development. In this role, you will lead the clinical pharmacology strategy for therapeutic programs while working closely with members from our Pharmacokinetics, Biomarkers, Clinical Development, Biometrics and Regulatory Affairs teams. You will apply Model-Informed Drug Development (MIDD) approaches to optimize clinical trial designs, justify dose selections, inform development decisions and mitigate risks across both early and late-stage development, acting as the clinical pharmacology voice on cross-functional program teams and in interactions with health authorities.

Responsibilities

Leading the clinical pharmacology strategy for assigned therapeutic programs, from first-in-human through Phase 2 and into late-stage planning; Applying model-informed drug development (MIDD) approaches to justify doses and dosing intervals, optimize study designs, and support go/no-go decisions; Recommending first-in-human starting doses and escalation schemes by integrating nonclinical PK/PD, toxicology, target engagement and translational biomarker data; Building integrated clinical pharmacology plans that address PK, PD, exposure-response, dose and regimen selection, immunogenicity, intrinsic and extrinsic factors, and formulation or route changes; Executing pharmacometric methodologies such as population PK/PD, PBPK, and QSP to understand exposure-response relationships and define quantitative criteria to support data-driven decisions; Designing and interpreting the clinical pharmacology components of trials, including dose escalation, bioavailability and absorption kinetics, target-mediated drug disposition, special populations, and bridging studies; Writing and reviewing the clinical pharmacology content of protocols, Investigator Brochures, clinical study reports, briefing documents, CTAs and INDs, and other documents supporting Regulatory interactions; Preparing for health authority meetings and drafting responses to clinical pharmacology questions; Managing CROs and modeling service providers to deliver high-quality analyses on time; Presenting results and recommendations to program teams and senior leadership; Helping shape the clinical pharmacology function at AbCellera, including its processes and standards

Requirements

PhD or PharmD in Pharmacology, Pharmaceutical Sciences, Pharmacometrics or a related quantitative discipline, with 8+ years of clinical pharmacology experience in the biotech or pharmaceutical industry (or an MSc and 12+ years of clinical pharmacology experience); Has led clinical pharmacology for therapeutic antibodies or other biologics, and understands concepts such as target-mediated drug disposition, immunogenicity, and drug absorption kinetics; Extensive hands-on experience with population PK and PK/PD, exposure-response modeling, pharmacometrics tools (e.g., NONMEM, Monolix, R) and methodologies (e.g. PBPK, QSP), and can critically review modeling work done by others; Has contributed clinical pharmacology content to regulatory submissions and health authority interactions (FDA, EMA, Health Canada, or others); Has managed CROs or external modeling service providers; Has experience incorporating Modelling & Simulation outcomes into regulatory documents (Investigator Brochures, Briefing books, IND filings, etc.); Thrives in a dynamic working environment, supporting and working with cross-functional teams; Able to express complex ideas in understandable ways and communicate effectively with people from different fields; Excellent documentation skills with impeccable attention to detail

Benefits

CAD $1,500 annual Active Lifestyle Allowance; Annual vacation; Professional development opportunities; Comprehensive health benefits; Equity; Annual bonus dependent on individual and company performance; 6% (non-match) RRSP contribution; Scientific and technical mentorship; Strong sense of community through work, clubs, and socials