Clinical Development Director, Respiratory Diseases

Jobgether; United States; Remote; USD 86,000 - 129,000; Full time

Benefits offered by this job

Fully remote (Canada)

Job summary

Jobgether seeks an experienced Clinical Science Lead to drive respiratory program development across the product lifecycle. You will shape evidence generation, ensure patient safety and study quality, and contribute to regulatory submissions and scientific publications.

The role emphasizes leadership, strategic planning and collaboration with regulators, payers, investigators and cross-functional teams. It is fully remote within Canada, with Ontario preferred.

Qualifications

• Bachelor’s degree in a science-related discipline.
• At least 3 years of significant clinical training and/or relevant clinical research experience including development planning.
• Strong knowledge of ICH, GCP, FDA requirements and regulatory and reimbursement evidence standards.
• Understanding of regulators', payers', and prescribers' needs in relevant markets.
• Thorough knowledge of clinical research methodology and biostatistics.
• Demonstrated ability to interpret complex datasets using statistical methods and visualization techniques.
• Experience applying digital tools to drive innovation in research.
• Strong communication, analytical thinking, decision-making, and strategic planning skills.
• Ability to influence stakeholders and lead in a matrix structure.
• Preferred: PhD or PharmD.
• Preferred: Experience leading cross-functional teams and respiratory drug development.
• Must be based in Canada; Ontario preferred; home-based.

Responsibilities

• Lead clinical development of respiratory programs across lifecycle.
• Generate and interpret evidence to evaluate efficacy, safety, and value for patients.
• Provide scientific oversight of evidence-generation activities to safeguard patient safety and study quality.
• Contribute to regulatory submissions and responses, including trial applications and briefing documents.
• Develop and review study documents, synopses, protocols, CSRs, abstracts, and manuscripts.
• Support Integrated Evidence Plans (IEPs) and Clinical Development Plans (CDPs).
• Align clinical strategies with scientific objectives, regulatory requirements, and commercial priorities.
• Manage development timelines and establish evidence-based decision criteria for milestones.
• Build relationships across Commercial, Research, Regulatory, Clinical Operations, Statistics, and others.
• Serve as a clinical development point of contact for senior management and cross-functional teams.
• Engage external stakeholders including regulators, payers, CROs, consultants, and investigators.
• Identify opportunities to improve clinical research approaches and adopt innovative tools.

Skills

Clinical development

ICH/GCP/FDA knowledge

Biostatistics

Data interpretation

Strategic planning

Stakeholder influence

Cross-functional leadership

Communication

Education

Bachelor’s degree in science

PhD or PharmD preferred

Job description

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.