Director, Clinical Scientist – Respiratory Indications

Job reputed company:

• Serve as clinical science reputed company and core 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 core 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

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