Clinical Development Lead, Pulmovant

🕒 September 22

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 25%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans, and reporting • Provide medical strategic oversight and accountability for study designs, protocol development, and regulatory documents with cross-functional teams • Lead execution and management of clinical studies, especially the Phase 3 trial, including study delivery, recruitment, site activation, data review and analysis, and reporting in compliance with GCP and regulatory standards • Monitor the therapeutic and regulatory landscape and provide guidance for program strategy • Collaborate with opinion leaders, Principal Investigators, internal clinicians, translational sciences, and clinical operations • Attend and present at investigator meetings and site initiation visits • Contribute to protocols, Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, and periodic clinical reports • Prepare abstracts, manuscripts, presentations, and clinical sections of regulatory documents • Maintain knowledge of ICH-GCP, external regulations, and procedures • Serve as primary medical accountability and oversight source, medical lead, liaison between investigators and internal study teams, and relationship manager for key opinion leaders and Health Authorities

🎯 Requirements

• MD/DO degree or equivalent is required • Minimum of 5–7 years’ experience conducting clinical research trials in the biopharmaceutical industry • Hands-on experience in protocol development and clinical trial monitoring • Strong written and verbal communication skills • Willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities • Ability to effectively give presentations at conferences, advisory meetings, and other public forums • Willingness to educate and mentor internal and external colleagues and collaborators • Strong ability to work within, lead, and motivate a cross-functional matrixed team • Scientific acumen and communication skills to influence and collaborate with scientific, regulatory, and business leaders • Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity • Ability to travel as needed • Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in cardiopulmonary/respiratory medicine is highly desirable • Experience with late-phase clinical development is ideally desired • Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable

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