Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.
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. If you are a clinical pharmacologist who is excited to use modeling and data to guide novel antibody therapies toward patients, we’d love to hear from you.
How you might spend your days
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.
We’d love to hear from you if
You have a 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)
You have led clinical pharmacology for therapeutic antibodies or other biologics, and understand concepts such as target-mediated drug disposition, immunogenicity, and drug absorption kinetics
You have 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
You have contributed clinical pharmacology content to regulatory submissions and health authority interactions (FDA, EMA, Health Canada, or others)
You have managed CROs or external modeling service providers
You have experience with incorporating Modelling & Simulations outcomes into regulatory documents (Investigator Brochures, Briefing books, IND filings, etc.)
You thrive in a…