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AbCellera · 3 weeks ago

Medical Director - Clinical Development - Endocrinology and Autoimmune Diseases

California

Full-time

Onsite

Director/Executive

12+ years exp

AbCellera is a clinical stage biotech company developing antibody therapeutics for endocrine and autoimmune diseases. The Medical Director will provide medical and scientific leadership for pipeline programs, overseeing clinical trials and ensuring compliance with safety and regulatory standards.

BiotechnologyMedicalTherapeutics

Comp. & Benefits

Responsibilities

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

Qualification

Clinical Development LeadershipClinical Trial DesignRegulatory ComplianceBiologic Agents ExperienceTranslational MedicineInterpersonal SkillsCommunication SkillsPresentation SkillsTeam Collaboration