Medical Director - Clinical Development - Endocrinology and Autoimmune Diseases

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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 that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. 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. How you might spend your days 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 We'd love to hear from you if You have an M.D. (Doctor of Medicine) or equivalent degree; Board Certification or eligibility in Endocrinology, Rheumatology, or Internal Medicine is preferred You have 12+ years of clinical development and leadership experience in the pharmaceutical or biotechnology industry You have a proven track record in the design, execution, and analysis of Phase 1-2 clinical trials You have excellent communication, presentation, and interpersonal skills, and are capable of influencing strategy across all levels of the organization You have experience with biologic agents (such as monoclonal antibodies), and/or novel modalities (bispecifics, T-cell engagers, ADC) You have experience interacting with major regulatory agencies (FDA, Health Canada, EMA) You have experience with translational medicine and biomarker development in clinical trials

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