Director, Clinical Scientist (Respiratory)

Accountabilities: You will provide scientific leadership and operational oversight for late-stage respiratory clinical development programs, ensuring high-quality trial execution and alignment with scientific and regulatory objectives. Your responsibilities will include: Serve as the clinical science lead and a core member of clinical development teams overseeing one or more respiratory studies in asthma and/or COPD. Support day-to-day clinical study execution, ensuring compliance with protocols, timelines, quality standards, and regulatory requirements. Lead and contribute to the development of late-stage clinical trial protocols and associated documentation, including clinical study plans, data review plans, case report forms (CRFs), database designs, and statistical analysis plans. Drive the preparation of clinical sections of regulatory documents, including Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and regulatory briefing materials. Participate in medical monitoring activities by reviewing and interpreting ongoing clinical data to ensure data quality, participant safety, and protocol compliance. Identify and escalate clinical or operational issues in collaboration with internal teams and external partners. Contribute to site selection, study initiation, and ongoing site engagement, providing scientific guidance to investigators and addressing protocol-related questions. Support clinical operations teams in study delivery, monitoring progress against milestones, identifying risks, and implementing mitigation strategies. Act as a key scientific point of contact for Contract Research Organizations (CROs) and external vendors. Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Safety teams to ensure coordinated trial execution. Prepare and present study updates, clinical data summaries, and key risks or issues during internal governance meetings. Maintain inspection readiness through high-quality documentation and support audit and regulatory inspection activities. Contribute to publication strategies, abstracts, scientific manuscripts, and other clinical communication materials. Support the development of Target Product Profiles (TPPs), clinical development plans, and risk-benefit assessments. Assist medical monitors with the management and oversight of committees for late-stage asthma studies, including Data and Safety Monitoring Boards (DSMBs) and Endpoint Adjudication Committees. Promote scientific rigor, accountability, transparency, and cross-functional collaboration while mentoring and supporting colleagues where appropriate. Communicate recommendations clearly, using clinical evidence and data to guide decisions, while adapting effectively to evolving priorities and complex challenges. Requirements : The ideal candidate is an experienced clinical development professional with strong scientific expertise in respiratory diseases and a proven ability to lead late-stage clinical studies. You should bring: An advanced degree such as a PhD, PharmD, MD, MS, or PMP certification. At least 9 years of industry experience in clinical development. Direct experience supporting or leading late-stage clinical trials in respiratory indications, particularly asthma and/or COPD. Strong knowledge of clinical research methodologies, clinical trial design, regulatory guidelines, and Good Clinical Practice (GCP). Demonstrated ability to lead clinical science strategy and execution across Phase 2 and Phase 3 studies. Proven experience authoring clinical trial protocols, Clinical Study Reports (CSRs), and regulatory documentation. Strong analytical skills and the ability to interpret complex clinical data and translate findings into actionable recommendations. Excellent written and verbal communication skills, including experience presenting scientific information to internal and external stakeholders. Strong cross-functional collaboration skills and the ability to work effectively with multidisciplinary teams and external partners. A proactive, solution-oriented mindset, with strong organizational skills and the ability to manage competing priorities. Demonstrated leadership capabilities, including accountability, mentorship, and the ability to foster an inclusive and high-performing team environment. Adaptability, resilience, and curiosity when navigating ambiguity and changing clinical development priorities. Additional experience that would be advantageous includes: Experience working with both small-molecule drugs and biologic therapies. Familiarity with artificial intelligence and machine learning-driven drug discovery platforms. Previous involvement in Biologics License Application (BLA) or Marketing Authorization Application (MAA) submissions. Benefits : Annual base salary range of $186,000–$279,000. Eligibility for an annual performance-based bonus. Equity compensation. Competitive employee benefits package. Remote work option for US-based candidates, with travel to headquarters as required by business needs. Opportunity to contribute to innovative clinical-stage drug development programs. Collaborative, multidisciplinary working environment. Opportunities to contribute to scientific innovation and the development of next-generation medicines.