Head of Analytical Development, Pulmovant
Pulmovant
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
pulmovant. com . About Roivant: Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 9 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms. In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. Position: Head of Analytical Development Summary: Pulmovant is seeking a highly skilled and experienced Head of Analytical Development to lead the analytical function. Reporting to the Executive Director, Pharmaceutical Development, the Head of Analytical Development will be accountable for the integrated analytical control strategy spanning the drug substance, the micronized active pharmaceutical ingredient (API), and the dry powder inhaler (DPI) drug product. This individual will lead the drug substance and drug product analytical teams and ensure that drug substance process and manufacturing changes are scientifically bridged to drug product performance and stability. The role will play a central role in NDA preparation, pre-approval inspection readiness, and the transition to commercial supply. We are seeking a leader with deep technical expertise in drug substance, solid-state, and particle characterization, combined with a strong understanding of inhaled drug product performance. The role involves close collaboration with drug substance process development, formulation, device, regulatory affairs, quality, and supply chain teams, as well as a multi-site network of contract development and manufacturing organizations (CDMOs).
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