Senior Manager – CMC Project Management

🔥 12 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 23%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• Provide program and project management support for Pulmovant’s drug development programs, particularly CMC activities supporting mosliciguat and the Phase 3 PHrontier trial • Build, maintain and communicate integrated CMC timelines aligned with clinical development and regulatory milestones • Own CMC team meeting cadence, including agendas, minutes, decisions and action-item tracking through closure • Maintain the program’s single source of truth for deliverables, owners and due dates • Track risks, issues, assumptions and dependencies; escalate early and drive resolution or mitigation • Partner with CMC technical leads across drug substance, drug product and analytical development to create executable project plans • Coordinate CDMO/CMO deliverables and hold external partners accountable to agreed dates • Maintain CMC budget and spend trackers; support purchase order, invoice and accrual reconciliation • Support routing of MSAs, SOWs and change orders with Legal and Procurement • Support CMC regulatory submission timelines, including IND/IMPD amendments, Module 3 content and NDA activities • Develop and maintain timelines, dashboards and status reports for stakeholders and leadership • Facilitate collaboration across CMC, Clinical Operations, Regulatory, Quality, Supply Chain and external partners • Prepare governance and leadership review materials, including program updates and key decision points • Contribute to continuous improvement of project management processes, templates and tools • Provide broader program and project management support across Pulmovant’s pipeline as needed

🎯 Requirements

• Bachelor’s degree in a scientific, engineering or other technical discipline, or equivalent practical experience • Senior Manager: 5+ years of relevant professional experience, including 2+ years in a project or program management capacity • Associate Director: 8+ years of relevant professional experience, 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; project management experience in another technical or regulated environment may be considered • Familiarity with drug substance and drug product development, analytical development, GMP manufacturing, and working through CDMOs/CMOs, or a credible plan to rapidly develop this familiarity • Experience managing projects beyond CMC, including clinical operations, regulatory affairs or general program management • Demonstrated experience building and maintaining integrated timelines in Smartsheet, Microsoft Project, Office Timeline, Planisware or equivalent • Experience supporting programs through Phase 1–3 clinical development is valued • Exceptional organization and attention to detail • Strong facilitation and disciplined follow-through • Ability to influence and create accountability without direct authority • Clear and concise written and verbal communication • Comfort with ambiguity and shifting priorities • Scientific and technical curiosity • Sound judgment and discretion; ability to operate independently in a lean, fast-paced clinical-stage biotech environment • Strong working proficiency with Excel, PowerPoint and SharePoint/Teams • Fluency or fast aptitude with timeline and dashboard tools • Flexibility to support project management outside CMC

🏖️ Benefits

• Periodic travel associated with the role • Equal employment opportunities and protection from discrimination and harassment