Principal Scientist, Clinical Pharmacology

The role

You will lead the clinical pharmacology strategy for antibody-based therapeutic programs from first-in-human through late-stage development. You will apply model-informed drug development approaches to optimize clinical trial designs and justify dose selections.

What you will do

• Leading the clinical pharmacology strategy for assigned therapeutic programs
• Applying model-informed drug development (MIDD) approaches to justify doses and optimize study designs
• Recommending first-in-human starting doses and escalation schemes
• Building integrated clinical pharmacology plans
• Executing pharmacometric methodologies such as population PK/PD, PBPK, and QSP
• Designing and interpreting the clinical pharmacology components of trials
• Writing and reviewing clinical pharmacology content for protocols, Investigator Brochures, and regulatory documents
• Preparing for health authority meetings and drafting responses
• Managing CROs and modeling service providers
• Presenting results and recommendations to program teams and senior leadership

Required qualifications

• 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 industr
• MSc and 12+ years of clinical pharmacology experience
• Led clinical pharmacology for therapeutic antibodies or other biologics
• Understand 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)
• Contributed clinical pharmacology content to regulatory submissions and health authority interactions (FDA, EMA, Health Canada, or others)
• Managed CROs or external modeling service providers
• Experience with incorporating Modelling & Simulations outcomes into regulatory documents
• Ability to express complex ideas in understandable ways
• Excellent documentation skills

Benefits

• Equity
• Annual bonus dependent on individual and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.