Director, Clinical Scientist – Respiratory Indications

Remote · USA Full-time New today

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:

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