Director, Clinical Scientist – Respiratory

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Act as the clinical science lead and integral member of clinical development teams focused on respiratory studies.

• Assist with the daily execution of studies in accordance with protocols, timelines, and regulatory standards.

• Create and develop clinical trial protocols along with related documentation.

• Lead the creation of clinical components for regulatory documents.

• Engage in medical monitoring and assess clinical data for quality, safety, and adherence to protocols.

• Involve in site selection, initiation, and continuous engagement.

• Offer scientific guidance to investigators and respond to protocol-related questions.

• Monitor study progress, recognize risks, and apply mitigation strategies.

• Serve as a primary scientific liaison for CROs and vendors.

• Collaborate with teams in Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Safety.

• Contribute to governance meetings, study progress updates, data summaries, and risk evaluations.

• Ensure readiness for inspections and aid in audit/inspection activities.

• Assist with publication strategies, abstracts, and manuscript preparation.

• Play a role in developing target product profiles, clinical development plans, and risk-benefit assessments.

• Support oversight committees for advanced-stage asthma studies.

• Cultivate an inclusive, high-performing team environment through mentorship and coaching.

⛳️ Requirements

• Advanced degree (PhD, PharmD, MD, MS, PMP).

• Over 9 years of experience in the clinical development sector.

• Direct experience with late-stage respiratory (asthma and/or COPD) studies.

• In-depth knowledge of clinical research methodologies, regulatory guidelines, and GCP.

• Proven capability to lead clinical science strategy and execution in late-stage trials.

• Exceptional analytical, communication, and cross-functional collaboration abilities.

• Previous experience in authoring clinical protocols, CSRs, and regulatory documents.

🏝️ Benefits

• Annual bonus.

• Equity compensation.

• Competitive benefits package.

• Option for remote work in the U.S. with travel to headquarters as necessary for business needs.