Senior Director, Clinical Development, Pulmovant

Pulmovant; United States; On-site; USD 180,000 - 250,000; Full time

Job summary

Pulmovant is seeking a highly motivated physician leader to design and execute clinical trial activities for mosliciguat, overseeing medical accountability and serving as the medical lead. The role requires liaison between investigators and the internal team and maintaining relationships with key opinion leaders and Health Authorities.

The Senior Director, Clinical Development will drive the Phase 3 trial execution, contribute to protocol concepts, and ensure high ethical, safety, and quality

Qualifications

• MD/DO or equivalent required.
• Significant experience leading Phase 3 clinical trials.
• Strong understanding of GCP, regulatory expectations and medical oversight.

Responsibilities

• Design and execute clinical trial activities to support mosliciguat development.
• Serve as medical lead and accountable physician for trials.
• Liaise between investigators and internal study team; maintain relationships with key opinion leaders and Health Authorities.
• Provide leadership for Phase 3 trial execution, data interpretation, and regulatory documents.
• Stay current on therapeutic landscape to guide program strategy.

Skills

Clinical development

Medical leadership

Study design

Regulatory knowledge

GCP compliance

Cross-functional leadership

Education

MD/DO or equivalent

Job description

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant's first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option 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 in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape.

Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life‑threatening condition with significant unmet medical needs for patients. PHocus 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, in conjunction with mosliciguat's once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD. These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here .

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

For more information, please visit https://www.pulmovant.com .

About Roivant: Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant's pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non‑infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT‑1402, a fully human monoclonal antibody targeting FcRn in development across several IgG‑mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or "Vants" to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com .

Position: Senior Director, Clinical Development

Position Summary: Pulmovant is seeking a highly motivated hands‑on physician leader who will be responsible for the design and execution of clinical trial activities to support the development of mosliciguat, including study design, protocol development, execution and data interpretation. The candidate will be the primary source of medical accountability and oversight for clinical trials and will serve as a medical lead. The candidate will liaise between investigators and the internal study team and will maintain established relationships with key opinion leaders as well as Health Authorities. Scope of responsibility will include a leading role on the execution of the Phase 3 trial and may also include indication lead activities for additional indications as the program is further developed.

Key Duties and Responsibilities

• Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans and reporting to drive high value clinical data.
• Medical strategic oversight and accountability for the formulation of study designs, protocol development, and regulatory documents in collaboration with cross‑functional team.
• Provide clinical leadership of trial execution and management of clinical studies with a focus on the phase 3 trial. Provide clinical leadership in the conduct of clinical activities including executional delivery of the study, recruitment, site activation, data review analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with GCP and regulatory standards.
• Remain current on the therapeutic landscape, including regulatory in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of programs.
• Collaborate with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
• Maintain