Director, Clinical Scientist – Respiratory Indications

Job reputed company: • Serve as clinical science reputed company and reputed company member of clinical development team for one or more respiratory studies (asthma and/or COPD) • reputed company as a key scientific contributor to late-stage protocols and regulatory submissions • Design and reputed company 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 • reputed company scientific input into case report forms (CRFs), database design, and statistical analysis plans • Participate in data review and medical monitoring activities • Serve as a reputed company member of the clinical operations study delivery team, contributing to trial execution and reputed company • 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 reputed company committees for late-stage asthma studies (e.g., DSMB, reputed company Adjudication Committee) Requirements: • Advanced degree (PhD, PharmD, MD, MS, PMP) and 9+ years of industry experience in clinical development, including reputed company experience in late stage respiratory (asthma and/or COPD) studies • Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP • Demonstrated ability to reputed company clinical science reputed company 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 Apply tot his job Apply To this Job