Clinical Development Director, Respiratory Diseases

- 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.

- 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.

- Fully…