Remote Respiratory Clinical Development Director

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

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.