Director, Clinical Scientist – Respiratory Indications

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