Clinical Development Lead

Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on transforming the lives of patients with pulmonary diseases. Their investigational candidate, mosliciguat, is designed as a novel, once-daily inhaled treatment for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial for PH-ILD, with broad applicability across pulmonary hypertension (PH) and interstitial lung disease (ILD) landscapes.

Pulmovant recently announced positive results from its Phase 2 PHocus study, evaluating mosliciguat for PH-ILD. The study met both primary and secondary endpoints, including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, combined with mosliciguat’s once-daily, inhaled administration and potential first-in-class profile, position it as a potential single-agent treatment and combination therapy for patients with PH-ILD. These data represent a significant advancement for a devastating disease affecting approximately 200,000 patients with limited treatment options. A Phase 3 trial is currently underway.

As part of the Roivant family, Pulmovant leverages collaboration and innovation to drive progress.

Position Summary:

Pulmovant is seeking a highly motivated, hands-on physician leader for the role of Clinical Development Lead (Senior Director level). This individual will be responsible for designing and executing clinical trial activities for mosliciguat, including study design, protocol development, execution, and data interpretation. The candidate will serve as the primary source of medical accountability and oversight for clinical trials, liaising between investigators, the internal study team, and key opinion leaders, as well as Health Authorities. Key responsibilities include leading the Phase 3 trial and potentially taking on indication lead activities for additional indications as the program progresses.

Key Duties and Responsibilities:

• Provide clinical and scientific input to study design, protocol concepts, statistical analysis plans, and reporting to drive high-value clinical data.
• Offer medical strategic oversight and accountability for study designs, protocol development, and regulatory documents in collaboration with cross-functional teams.
• Provide clinical leadership for trial execution and management, focusing on the Phase 3 trial. Ensure executional delivery of the study, including recruitment, site activation, data review, analysis, and reporting that adheres to the highest ethical, safety, and quality standards, in compliance with GCP and regulatory standards.
• Stay current on the therapeutic landscape, including regulatory developments in relevant therapeutic areas, through scientific literature reviews, interactions with key opinion leaders, and attendance at scientific meetings, to provide input and guidance for program strategy.
• Collaborate with external opinion leaders, Principal Investigators, internal clinicians, translational sciences, and clinical operations to ensure appropriate study designs for successful data analysis and achievement of intended study outcomes.
• Maintain awareness of development and regulatory issues related to competitive compounds and how Pulmovant’s program fits into the competitive landscape.
• Attend and present at investigator meetings and site initiation visits as applicable.
• Provide clinical leadership and contribute to the preparation of protocols, Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
• Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings, as well as author clinical sections of regulatory documents (e.g., Investigator Brochures, IND sections).
• Maintain knowledge of ICH-GCP, external regulations, and procedures.

Skills, Qualifications, and Requirements:

• An MD/DO degree or equivalent is required.
• Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in cardiopulmonary/respiratory medicine is highly desirable.
• Minimum of 5–7 years of experience conducting clinical research trials in the biopharmaceutical industry, ideally with late-phase experience.
• Hands-on experience in protocol development and clinical trial monitoring.
• Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable.
• Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities; and ability to present at conferences, advisory meetings, and public forums.
• Willingness to educate and mentor internal and external colleagues and collaborators.
• Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in a highly dynamic environment and embrace uncertainty.
• Self-motivated; strong commitment to follow up on tasks and action items; organizational, analytical, and problem-solving skills; risk identification and management; creative and innovative thinking.
• Strong ability to work within and lead and motivate a cross-functional matrixed team.
• The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders.
• Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity.
• Ability to travel as needed.