Director, Clinical Supply, 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  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: Director, Clinical Supply Summary: Pulmovant is seeking a leader in Clinical Supply who will provide planning and execution of Clinical Supply Chain activities to support Pulmovant clinical studies globally. This position coordinates operations including clinical packaging, labeling, and distribution. Responsible for actively managing all inventory, logistics and forecasting for the clinical program. This person will be the subject matter expert related to clinical drug supply during all phases of the clinical trial and will support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs, corporate objectives and is responsible for vendor management including performance metrics. Key   Duties and Responsibilities  Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials Manage, coach and mentor Clinical Supply Managers Act as primary liaison with contractor(s) (CMO's). Complete business and performance metrics Work with CMC, Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements Manage development of pharmacy manuals with appropriate internal subject matter experts Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities as required. Work with Regulatory Compliance and QA in selection/qualification of CMO's Subject matter expert for clinical trial supply during regulatory inspections Proactively address risk management issues and implement business continuity plans Education and Experience  Minimum of 8 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management Prior investigational drug product experience and prior GCP training is required Recent industry experience with clinical supplies or clinical operations is preferred Essential   Skills and   Abilities  Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders Proven ability to select, secure and manage external vendors to achieve results and control expenditures Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double, blind, placebo controlled) Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure Experience with regulatory submissions a plus The duties of this role are generally conducted