Senior Manager / Associate Director, CMC Project Management, Pulmovant

Openkrill; United States; Teletrabalho; USD 120 000 - 190 000; Tempo integral

Resumo da oferta

Pulmovant seeks a Senior Manager / Associate Director, CMC Project Management to drive program-level PM for mosliciguat across the PHrontier Phase 3 program. You will build and maintain integrated CMC timelines, coordinate with CDMOs/CMOs, and manage budgets while aligning with Regulatory, Clinical, and Quality functions.

The role emphasizes organization, facilitation, and follow-through in a multi-vendor, regulated biotech environment.

Qualificações

• 5+ years of relevant professional experience; 2+ years in PM/Program PM.
• Biopharmaceutical CMC experience strongly preferred.
• Familiarity with drug substance/product development, analytical development, GMP manufacturing, and CDMO/CMO interactions.
• Experience managing projects beyond CMC (clinical operations, regulatory affairs or general program management).
• Demonstrated experience building and maintaining integrated timelines in planning tools (Smartsheet, MS Project, Office Timeline, Planisware).
• Experience supporting programs through clinical development (Phase 1–3) is valued; late-stage experience a plus.

Responsabilidades

• Build, maintain, and communicate integrated CMC timelines aligned with clinical milestones.
• Own CMC team meeting cadence: agendas, minutes, decisions, action tracking.
• Maintain single source of truth for deliverables, owners and due dates; keep current.
• Track risks, issues, assumptions and dependencies across CMC and cross-functional workstreams; elevate and mitigate.
• Coordinate CDMO/CMO deliverables with quality and regulatory leads; track dates.
• Maintain budgets and spend trackers; support PO, invoices, accruals, and vendor agreements.

Conhecimentos

Organization

Attention to detail

Cross-functional collaboration

Formação académica

Bachelor’s degree in a scientific/engineering discipline

PMP/PgMP certification (plus)

Ferramentas

Smartsheet

Microsoft Project

Office Timeline

Planisware

Descrição da oferta de emprego

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: 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

• 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).
• Own the CMC team meeting cadence — agendas, minutes, decisions, and tracking of action items through to closure.
• Maintain the program’s single source of truth for deliverables, owners and due dates, and keep it current without being asked.
• Track risks, issues, assumptions and dependencies across CMC and cross-functional workstreams; elevate early and drive resolution or mitigation.
• Partner with CMC technical leads across drug substance, drug product and analytical development to translate technical strategy into executable, risk-mitigated project plans.
• 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.
• 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.
• Support CMC regulatory submission timelines (IND/IMPD amendments, Module 3 content, NDA), tracking authoring, review and approval milestones in partnership with Regulatory Affairs.
• Develop and maintain program management tools — timelines, dashboards and status reports — that give internal stakeholders and leadership clear visibility into CMC progress.
• Facilitate effective communication and collaboration across CMC, Clinical Operations, Regulatory, Quality, Supply Chain and external partners.
• Prepare materials for governance and leadership reviews, including program updates and key decision points.
• Contribute to continuous improvement of project management processes, templates and tools as Pulmovant scales.
• Flexible to be able to go into broader program and project management support across Pulmovant’s pipeline.

Education and Experience

• 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.
• 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.
• 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.
• 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.
• Experience managing projects beyond CMC (clinical operations, regulatory affairs or general program management)
• 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.
• Experience supporting programs through clinical development (Phase 1–3) is valued; late-stage or registrational experience is a plus, not a requirement.

Essential Skills and Abilities

• Exceptional organization and attention to detail — able to hold a large, constantly moving set of deliverables, owners and dates and ke