Clinical Development Director, Respiratory Diseases

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Development Director, Respiratory Diseases based in Canada. Take a leading role in advancing clinical research and developing innovative treatments for respiratory diseases. In this senior scientific position, you will shape clinical development strategies and oversee studies across multiple stages of medicine development. You will work closely with global, cross-functional teams to generate robust evidence on treatment efficacy, safety, and patient value. Combining scientific expertise, strategic thinking, and clinical research leadership, you will help guide critical development decisions and regulatory interactions. You will collaborate with internal stakeholders and external experts to ensure clinical programs meet regulatory standards and address unmet medical needs. This fully remote opportunity is open to candidates across Canada, with a preference for those based in Ontario, and offers the chance to contribute to meaningful advances in respiratory healthcare. Accountabilities - Lead the clinical development of respiratory disease programs, supporting the design, planning, execution, and delivery of clinical studies across the development lifecycle. - Generate and interpret clinical evidence to evaluate a medicine’s potential efficacy, safety profile, differentiation, and value to patients as efficiently as possible. - Provide scientific oversight of evidence-generation activities to safeguard patient safety, maintain study quality, and support timely delivery. - Contribute to regulatory submissions and interactions, including clinical trial applications, briefing documents, presentations, and responses to regulatory questions. - Develop and review clinical study documents, including study synopses, protocols, clinical study reports, abstracts, and scientific manuscripts.

- Support the development and ongoing management of Integrated Evidence Plans (IEPs) and Clinical Development Plans (CDPs) for assets in development. - Align clinical strategies and study designs with scientific objectives, regulatory requirements, commercial priorities, and patient needs. - Manage clinical development timelines and establish evidence-based decision criteria to support key development milestones and go/no-go decisions. - Build effective working relationships across Commercial, Research, Regulatory, Clinical Operations, Statistics, and other relevant functions. - Serve as a clinical development point of contact for senior management and cross-functional leadership teams, both internally and externally. - Engage and influence external scientific stakeholders, including regulators, payers, contract research organizations (CROs), consultants, and clinical investigators. - Identify opportunities to improve clinical research approaches, introduce innovative tools and methods, and advance strategic initiatives across Clinical Sciences. Requirements - Bachelor’s degree in a science-related discipline. - At least 3 years of significant clinical training and/or relevant clinical research experience, including an understanding of clinical development planning and the progression of clinical trials from initial concept through publication. - Strong knowledge of International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), FDA requirements, and relevant regulatory and reimbursement evidence standards. - Understanding of the needs and priorities of regulators, payers, and prescribers in relevant markets. - Thorough knowledge of clinical research methodology and biostatistics, with the ability to support innovative, efficient clinical trial designs and evidence-based development plans.