Senior Manager, 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.

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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: Senior Manager, Clinical Supply

Summary:

Pulmovant is seeking a leader in Clinical Supply who will provide 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 and logistics 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

• Support all clinical supply activities for on-going and new clinical trials for on-time delivery, which includes protocol demand forecasting, pharmacy manual drafting, trial monitoring, initial and resupply planning, and distribution activities.

• Coordinate closely with Clinical Operations, CRO and sites to support enrollment and ongoing participant dosing.

• Assist in coordination with contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials ensuring compliance with cGxP requirements.

• Partner with CMC, Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions.

• Participate in and lead IXRS development efforts and system maintenance where applicable.

• Assist in development of risk mitigation plans to proactively identify any potential issues that may impact drug supply including process development for inspection readiness.

• Support 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.

• Coordinate with CMC team regarding logistics and movement of material globally to support manufacturing and drug development.

Education and Experience

• Minimum of 5 years of related experience in the pharmaceutical industry with at least 2 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.

• 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.

• The duties of this role are generally conducted in a remote environment. As is typical of a remote-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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