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.