Medical Director - Clinical Development - Endocrinology and Autoimmune Diseases Job at AbCellera Biologics (Vancouver)

Job Description

AbCellera is a clinical stage biotech company developing antibody therapeutics for endocrine and autoimmune diseases. Our discovery platform integrates biology, computation, and engineering to develop impactful antibody-based medicines. We’re scientists, engineers, and business professionals who work together to turn scientific insights into breakthrough medicines. We pursue truth and scientific rigor. We think independently, act with conviction, and have the courage to work at the edge of the unknown. We offer the opportunity to stretch and explore, and to work on things that matter. We are seeking a Medical Director to join our Clinical Development team, to provide medical and scientific leadership for our pipeline programs in the areas of endocrinology and autoimmune diseases from pre-IND/CTA stage through Phase 1/FIH and later stage trials. You will lead the cross-functional program team and drive the development strategy, including study design, execution, interpretation, and reporting of clinical trials, ensuring the highest standards of safety and regulatory compliance.

Job Responsibility

Leading the medical strategy for assigned clinical development programs in endocrinology and/or autoimmune diseases
Designing and authoring clinical protocols (Phase 1-3), investigator brochures, clinical study reports (CSRs), and regulatory documents (IND, CTA)
Serving as the Medical Monitor for assigned trials, overseeing patient eligibility, safety, and protocol adherence
Interpreting clinical trial data, including safety, efficacy, and pharmacokinetics/pharmacodynamics (PK/PD), and translate findings into actionable development strategy
Providing medical expertise for the ongoing assessment and management of patient safety, including reviewing cumulative safety data, serious adverse events (SAEs) and contributing to safety reports (DSURs)
Ensuring all clinical development activities are conducted in accordance with Good Clinical Practice (GCP), relevant regulatory requirements, and company standard operating procedures (SOPs)
Serving as the primary clinical contact for assigned programs to internal teams, external investigators, and regulatory agencies
Establishing and maintaining collaborative relationship with medical experts and investigators in the assigned therapeutic areas of development
Collaborating closely with cross-functional teams, including Translational Science, Clinical Operations, Regulatory Affairs, Biostatistics, and Corporate Development
Developing publications, present data and strategy to governance committees and at external meetings

Requirements

M.D. (Doctor of Medicine) or equivalent degree
Board Certification or eligibility in Endocrinology, Rheumatology, or Internal Medicine is preferred
12+ years of clinical development and leadership experience in the pharmaceutical or biotechnology industry
Proven track record in the design, execution, and analysis of Phase 1-2 clinical trials
Excellent communication, presentation, and interpersonal skills, and are capable of influencing strategy across all levels of the organization
Experience with biologic agents (such as monoclonal antibodies), and/or novel modalities (bispecifics, T-cell engagers, ADC)
Experience interacting with major regulatory agencies (FDA, Health Canada, EMA)
Experience with translational medicine and biomarker development in clinical trials

What we offer

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

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Medical Director - Clinical Development - Endocrinology and Autoimmune Diseases

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