Senior Manager / Associate Director, CMC Project Management, Pulmovant at Pulmovant

RemoteFull-timeRemoteProject ManagementPosted 4 days ago

About the Role

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 <a href="https://investor.roivant.com/news-releases/news-release-details/roivant-announces-positive-results-phocus-study-mosliciguat">here</a>.  As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.  For more information, please visit <a href="https://www.pulmovant.com/">https://www.pulmovant.com</a>.  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 <a href="http://www.roivant.com/">www.roivant.com</a>.     Position: Senior Manager / Associate Director, CMC Project Management  Location: Remote (US-based), with periodic travel  Title and level will be set based on the experience of the successful candidate.  Summary: The Senior Manager / Associate Director, CMC Project Management will provide program and project management support for Pulmovant’s drug development programs, with a particular focus on Chemistry, Manufacturing, and Controls (CMC) activities supporting mosliciguat development and the Phase 3 PHrontier trial. Reporting to the Senior Director, CMC Project Management, this individual will build and maintain integrated CMC timelines, run the CMC team meeting cadence, track deliverables, risks and budgets, and drive alignment across CMC, Clinical, Regulatory, Quality and external CDMO/CMO partners.  This is a project management role rather than a technical lead role. The core of the job is organization, facilitation, tracking and follow-through — keeping a complex, multi-vendor program visible, honest and on schedule. Accordingly, we will consider a broad range of backgrounds: experienced CMC project managers, scientific or manufacturing professionals who have been managing projects as part of their current role, and strong project managers from adjacent technical or regulated industries who have the aptitude and motivation to come up the CMC learning curve quickly. If you meet most but not all of the items below, we encourage you to apply.    Key Duties and Responsibilities  <ul> <li>Build, maintain and communicate integrated CMC timelines, ensuring alignment with overall clinical development and regulatory milestones (e.g., the PHrontier Phase 3 trial and subsequent filings). </li> <li>Own the CMC team meeting cadence — agendas, minutes, decisions, and tracking of action items through to closure. </li> <li>Maintain the program’s single source of truth for deliverables, owners and due dates, and keep it current without being asked. </li> <li>Track risks, issues, assumptions and dependencies across CMC and cross-functional workstreams; escalate early and drive resolution or mitigation. </li> <li>Partner with CMC technical leads across drug substance, drug product and analytical development to translate technical strategy into executable, risk-mitigated project plans. </li> <li>Coordinate CDMO/CMO deliverables in partnership with technical and quality leads — meeting cadence, deliverable and document tracking, and holding external partners accountable to agreed dates. </li> <li>Maintain budget and spend trackers for CMC activities; support purchase order, invoice and accrual reconciliation with Finance, and support routing of MSAs, SOWs and change orders with Legal and Procurement. </li> <li>Support CMC regulatory submission timelines (IND/IMPD amendments, Module 3 content, NDA), tracking authoring, review and approval milestones in partnership with Regulatory Affairs. </li> <li>Develop and maintain program management tools — timelines, dashboards and status reports — that give internal stakeholders and leadership clear visibility into CMC progress. </li> <li>Facilitate effective communication and collaboration across CMC, Clinical Operations, Regulatory, Quality, Supply Chain and external partners. </li> <li>Prepare materials for governance and leadership reviews, including program updates and key decision points. </li> <li>Contribute to continuous improvement of project management processes, templates and tools as Pulmovant scales. </li> <li>Flexible to be able to go into broader program and project management support across Pulmovant’s pipeline. </li> </ul> Education and Experience  <ul> <li>Bachelor’s degree in a scientific, engineering or other technical discipline, or equivalent practical experience; advanced degree a plus. PMP, PgMP or equivalent certification a plus but not required. </li> <li>Senior Manager: 5+ years of relevant professional experience, including 2+ years in a project or program management capacity. Associate Director: 8+ years, including 4+ years in a project or program management capacity. Equivalent combinations of education and experience will be considered. </li> <li>Biopharmaceutical CMC experience is strongly preferred. We will also consider candidates with a demonstrated project management track record in another technical or regulated environment — for example pharmaceutical or device manufacturing, engineering, clinical operations, laboratory or quality operations — who are motivated to build CMC depth. </li> <li>Familiarity with (or a credible plan to rapidly develop familiarity with) drug substance and drug product development, analytical development, GMP manufacturing, and working through CDMOs/CMOs. </li> <li>Experience managing projects beyond CMC (clinical operations, regulatory affairs or general program management)  </li> <li>Demonstrated experience building and maintaining integrated timelines in a recognized planning tool (Smartsheet, Microsoft Project, Office Timeline, Planisware or equivalent), and driving cross-functional teams to deliver against them. </li> <li>Experience supporting programs through clinical development (Phase 1–3) is valued; late-stage or registrational experience is a plus, not a requirement. </li> </ul> Essential Skills and Abilities  <ul> <li>Exceptional organization and attention to detail — able to hold a large, constantly moving set of deliverables, owners and dates and keep it accurate and trustworthy. </li> <li>A natural facilitator: runs a meeting that starts on time, stays on the agenda, surfaces the real issue, and closes with clear decisions, owners and dates. </li> <li>Disciplined follow-through — tracks commitments against stated goals and objectives and closes the loop on every action item. </li> <li>Able to influence and create accountability without direct authority, across internal functions and external vendors. </li> <li>Clear and concise written and verbal communication; can distill a complex technical discussion into a one-page update that a non-technical executive can act on. </li> <li>Comfortable with ambiguity and shifting priorities; good instincts for what to escalate and what to absorb. </li> <li>Scientific and technical curiosity — genuinely interested in understanding the underlying CMC work, not just the schedule around it. </li> <li>Sound judgment and discretion, with the ability to operate independently in a lean, fast-paced, growing clinical-stage biotech environment. </li> <li>Strong working proficiency with Excel, PowerPoint and SharePoint/Teams, and fluency (or fast aptitude) with timeline and dashboard tools. </li> <li>Flexible with an “all-hands” mindset; willing and able to step into project management support outside CMC. </li> </ul>   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!

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