Pulmovant

Lead and oversee clinical trial execution, vendor management, and risk mitigation for Phase 2 and 3 pulmonary disease trials. | Extensive experience in clinical operations, leadership in biotech or pharma, and expertise in respiratory or pulmonary clinical development. | 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 participants dosed 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. For more information, please visit https://www.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; 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: Head of Clinical Operations Summary: The Head of Clinical Operations will be responsible for establishing the clinical operations function for an incubating portfolio company (Vant) focused on development of first- and best- in class treatments in pulmonary diseases. S/he will lead and oversee execution of clinical program to progress programs forward within the portfolio. S/he will proactively identify and mitigate risks, lead from the front and collaborate with the Head of Clinical Development and SVP, Clinical Operations to improve timelines, ensure operational planning and execution excellences, and budgeting for the clinical program. This is an opportunity to play an instrumental role in bringing a novel therapy to market with blockbuster commercial potential while providing better treatment options for patients living with pulmonary diseases. Key Duties and Responsibilities Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity Responsible for the successful planning and execution of Phase 2 and 3 trials Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience Develops and optimizes critical SOPs needed for program success, inspection readiness and compliance Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships Provide scientific/clinical expertise in the design and interpretation of clinical studies Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods Provide direct line management and training/mentoring of Clinical Operations team members Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained Participate in business development and process improvement/quality initiatives, as needed Education and Experience Bachelor's Degree in a scientific discipline; with a minimum of 12-15 years clinical development experience. Extensive clinical operations management experience, including program leadership or TA leadership at a minimum Proven excellence in clinical operations strategy and execution, including Ph I-IV studies, global clinical trial operations, and multiple clinical trials simultaneously. Experience in Respiratory/Pulmonary diseases preferred Hands-on, detail-oriented leader with operational fluency Demonstrated ability to set and prioritize goals and objectives, excellent time management, negotiation, problem-solving and organizational skills Experience in building infrastructure (including SOPs) required Ability to work independently and collaboratively in a fast-paced, matrixed team environment consisting of internal and external team members Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines Strong leadership skills with ability to innovate and collaborate with a small team to articulate clear clinical strategy. Strong coaching and mentoring skills leading to the success and development of subordinates Willingness to work across all levels to support Clinical Operations success Strong communication and presentation skills Willingness/ability to travel (domestic and international) 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!

Manage regulatory documentation, oversee submissions, and ensure compliance with FDA and global regulations. | 7+ years in pharmaceutical regulatory affairs, experience with FDA submissions, proficiency in Word, PDF, Veeva RIM, and DocuBridge, and experience with IND/NDA/BLA submissions. | 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 participants dosed 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. For more information, please visit https://www.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; 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: Senior Manager of Regulatory Documentation and Operations Summary: The Senior Manager of Regulatory Documentation and Operations will be responsible for managing the documentation and regulatory operations infrastructure and overseeing with the regulatory publishing and document management needs for Pulmovant. This position in consultation and alignment with the SVP of regulatory affairs and quality is accountable for all regulatory operations activities. This includes regulatory document formatting and finalization, archiving, submissions planning, publishing, QC, and submissions. The role will require direct hands-on contributions. A successful candidate must have significant experience using Microsoft Word, Adobe PDF, Veeva RIM, and DocuBridge handling a variety of regulatory submissions from early phase through post-approval. US FDA experience is essential, global experience is strongly preferred. Responsibilities: Able and willing to do hands on document formatting and regulatory publishing. Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements. Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving. Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy. Requirements: BA/BS degree required with 7+ years of pharmaceutical industry experience with 5+ years in regulatory affairs Knowledge of FDA submission expectations is required. Additional experience with ex-US is preferred. Must be solution oriented. Must be able to handle all aspects of regulatory operations (document and submission processing) Must have solid experience using Word and PDF files utilizing Veeva RIM and DocuBridge systems Have successfully completed IND and/or NDA/BLA submissions activities. Preferred if also handled medical device submissions and post-approval activities. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders. Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company. Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model. Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.

The Associate Director, Clinical Supply will oversee planning and execution of Clinical Supply Chain activities, including clinical packaging, labeling, and distribution. This role also involves managing inventory, logistics, and vendor relationships to ensure compliance with regulatory requirements. | Candidates should have a minimum of 7 years of experience in the pharmaceutical industry, with at least 5 years in Global Clinical Supply Management. Prior experience with investigational drug products and GCP training is required. | 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 participants dosed 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. For more information, please visit https://www.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; 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. 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. 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. 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 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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!