Director, Clinical Scientist – Respiratory Indications
Posted 2026-05-05
Remote, USA
Full-time
Immediate Start
- Job Description:
- Serve as clinical science lead and core member of clinical development team for one or more respiratory studies (asthma and/or COPD)
- Act as a key scientific contributor to late-stage protocols and regulatory submissions
- Design and develop clinical trial protocols and associated documents in collaboration with the clinical development leader
- Drive development of clinical study plans, data review plans, and clinical components of regulatory documents (e.g., IBs, CSRs, briefing books)
- Interpret clinical data in collaboration with cross-functional colleagues and external partners
- Provide scientific input into case report forms (CRFs), database design, and statistical analysis plans
- Participate in data review and medical monitoring activities
- Serve as a core member of the clinical operations study delivery team, contributing to trial execution and oversight
- Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams to ensure alignment and trial execution
- Support development and execution of publication plans, abstracts, and manuscripts
- Contribute to TPPs, clinical development plans, and risk-benefit assessments
- Support medical monitor with management of oversight committees for late-stage asthma studies (e.g., DSMB, Endpoint Adjudication Committee)
- Requirements:
- Advanced degree (PhD, PharmD, MD, MS, PMP) and 9+ years of industry experience in clinical development, including direct experience in late stage respiratory (asthma and/or COPD) studies
- Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP
- Demonstrated ability to lead clinical science strategy and execution in late-stage trials
- Excellent analytical, communication, and cross-functional collaboration skills
- Prior experience authoring clinical protocols, CSRs, and regulatory documents
- Benefits:
- Annual bonus
- Equity compensation
- Competitive benefits package