Job Details

Job Description

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant's first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participantsdosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Enrollment in a phase 2 trial is ongoing.

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; 8 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: Associate 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 study. 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 and contractual agreements.

KeyDuties 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. Develop best in class clinical supply area.
• Act as primary liaison with contractor(s) (CMO's). Complete business and performance metrics. Negotiate quotes and work orders for new trials.
• 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.
• Prepare clinical study supply forecasts as required.

Education and Experience

• Minimum of 7 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.

EssentialSkills andAbilities

• 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 in an office environment. As is typical of an office-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.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!