Clinical Development Director, Respiratory Diseases

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. Demonstrated ability to interpret complex datasets using statistical methods and visualization techniques, drawing accurate conclusions to inform clinical and strategic decisions. Experience applying digital tools and new approaches to drive innovation and improve research or development processes. Strong communication, analytical thinking, decision-making, and strategic planning skills. Ability to influence stakeholders, lead through a matrix structure, foster collaboration, and build productive relationships across multidisciplinary teams. Preferred: PhD or PharmD degree. Preferred: Experience leading cross-functional teams and motivating colleagues to deliver high performance. Preferred: Previous experience as a Clinical Science Lead (CSL) or in a comparable clinical development leadership role. Preferred: Significant experience in respiratory clinical drug development, including knowledge of respiratory diseases, underlying biology, and potential therapeutic targets. Must be based in Canada; Ontario is the preferred location. The role is home-based. Benefits Fully remote work arrangement within Canada, with a preference for candidates located in Ontario. Opportunity to contribute to the development of treatments addressing significant unmet needs in respiratory diseases. Exposure to complex clinical development programs and collaboration with multidisciplinary, global teams. Opportunities to influence scientific strategy, clinical trial design, and key development decisions. A collaborative environment that supports professional growth, scientific innovation, and continuous learning. Access to an inclusive workplace culture focused on patient impact, accountability, and employee development. Opportunity to apply emerging digital tools and innovative approaches to clinical research and evidence generation. Compensation and benefits: The original posting does not specify a salary range or detailed benefits package for this role. Specific compensation and benefits should be confirmed during the recruitment process.