Senior Clinical Scientist

We are seeking an experienced Senior Clinical Scientist to join our growing Clinical Development team, to drive early-phase development in oncology and endocrinology indications. Reporting to VP of Clinical Development and in collaboration with a Medical Director, you will integrate preclinical findings into clinical strategies and design Phase 1-2 clinical trials, author clinical study protocols and regulatory filings (INDs and CTAs) to advance novel drug candidates into clinic, execute early phase studies, and deliver proof-of-concept.

Responsibilities

Study design and strategy: evaluating preclinical data and scientific concepts to develop clinical study Protocols, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs) for Phase 1–2 dose escalation and expansion studies; Regulatory submissions: authoring clinical sections for global IND and CTA submissions, responding to inquiries from health authorities (FDA, EMA, HC), preparing protocol amendments, and contributing to Clinical Study Reports (CSRs); Medical monitoring and patient safety oversight: supporting the Medical Director with medical monitoring and data review activities, evaluating safety, efficacy, PK and PD trends, and preparing and presenting data at Safety Monitoring Committee (SMC) meetings to drive dose decisions; Cross-functional leadership and integration: acting as the Clinical Development liaison across the organization, collaborating with Translational Science, Biometrics and Data Management, Regulatory Affairs, Clinical Operations, and Quality Assurance; External engagement: engaging with medical experts and study investigators throughout the study cycle, contributing to advisory boards to refine clinical strategy and discuss study outcomes

Requirements

Advanced scientific degree (Ph.D., PharmD, M.S. in Life Sciences, or equivalent; MD welcomed); 5+ years of experience in biopharmaceutical clinical development, with at least 1 year dedicated to early-phase (Phase 1–2) clinical trials; Demonstrated background in Oncology or Endocrinology/Metabolic diseases; Knowledge of GCP, ICH guidelines, clinical trial design, medical monitoring, data review, dose-finding strategies, PK and PD assessments; Strong problem-solving skills, able to navigate complex operational and scientific challenges

Nice to have

MD welcomed

Benefits

Equity; Annual bonus dependent on team 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 is a priority; Strong sense of community and connections across AbCellera through work, clubs, and socials