Senior Manager – CMC Project Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide program and project management assistance for Pulmovant’s drug development initiatives, especially CMC activities related to mosliciguat and the Phase 3 PHrontier trial.

• Develop, maintain, and communicate integrated CMC timelines that align with clinical development and regulatory milestones.

• Oversee the CMC team meeting schedule, including agendas, minutes, decisions, and action-item tracking until resolution.

• Keep the program’s single source of truth updated for deliverables, owners, and due dates.

• Monitor risks, issues, assumptions, and dependencies; escalate promptly and drive resolution or mitigation as needed.

• Collaborate with CMC technical leads across drug substance, drug product, and analytical development to formulate executable project plans.

• Coordinate CDMO/CMO deliverables and ensure external partners adhere to agreed timelines.

• Maintain CMC budget and expenditure trackers; assist with purchase orders, invoice management, and accrual reconciliation.

• Aid in the routing of MSAs, SOWs, and change orders with the Legal and Procurement teams.

• Support CMC regulatory submission timelines, encompassing IND/IMPD amendments, Module 3 content, and NDA activities.

• Create and sustain timelines, dashboards, and status reports for stakeholders and leadership.

• Foster collaboration among 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 the ongoing enhancement of project management processes, templates, and tools.

• Provide overarching program and project management support across Pulmovant’s pipeline as necessary.

⛳️ Requirements

• Bachelor’s degree in a scientific, engineering, or other technical field, or equivalent practical experience.

• Senior Manager: 5+ years of relevant professional experience, including a minimum of 2 years in a project or program management role.

• Associate Director: 8+ years of relevant professional experience, including at least 4 years in a project or program management position.

• Equivalent combinations of education and experience will be taken into account.

• Biopharmaceutical CMC experience is highly preferred; project management experience in another technical or regulated setting may be considered.

• Understanding of drug substance and drug product development, analytical development, GMP manufacturing, and experience working with CDMOs/CMOs, or a credible plan to quickly gain this understanding.

• Experience managing projects beyond CMC, including clinical operations, regulatory affairs, or general program management.

• Proven track record in building and maintaining integrated timelines using Smartsheet, Microsoft Project, Office Timeline, Planisware, or similar tools.

• Experience supporting programs throughout Phase 1–3 clinical development is appreciated.

• Exceptional organizational skills and attention to detail.

• Strong facilitation abilities and disciplined follow-through.

• Capacity to influence and establish accountability without direct authority.

• Clear and concise written and verbal communication skills.

• Comfort in dealing with ambiguity and shifting priorities.

• Scientific and technical curiosity.

• Sound judgment and discretion; ability to work independently in a lean, fast-paced clinical-stage biotech environment.

• Strong working proficiency in Excel, PowerPoint, and SharePoint/Teams.

• Fluency or quick aptitude with timeline and dashboard tools.

• Willingness to support project management activities outside of CMC.

🏝️ Benefits

• Periodic travel associated with the role.

• Equal employment opportunities and protection from discrimination and harassment.