Senior Manager / Associate Director, CMC Project Management, Pulmovant

About Roivant

Location

• Remote (US-based), with periodic travel
• Title and level will be set based on the experience of the successful candidate.

Summary

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; escalate 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.
• Flex ible to be able to go into broader program and project management support across Pulmovant’s pipeline.

Education and Experience

Essential Skills and Abilities

• 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.
• 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.
• Disciplined follow-through — tracks commitments against stated goals and objectives and closes the loop on every action item.
• Able to influence and create accountability without direct authority, across internal functions and external vendors.
• 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.
• Comfortable with ambiguity and shifting priorities; good instincts for what to escalate and what to absorb.
• Scientific and technical curiosity — genuinely interested in understanding the underlying CMC work, not just the schedule around it.
• Sound judgment and discretion, with the ability to operate independently in a lean, fast-paced, growing clinical-stage biotech environment.
• Strong working proficiency with Excel, PowerPoint and SharePoint/Teams, and fluency (or fast aptitude) with timeline and dashboard tools.
• Flexible with an “all-hands” mindset; willing and able to step into project management support outside CMC.
• 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!

Requirements

• 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.
• 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.
• Disciplined follow-through — tracks commitments against stated goals and objectives and closes the loop on every action item.
• Able to influence and create accountability without direct authority, across internal functions and external vendors.
• 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.
• Comfortable with ambiguity and shifting priorities; good instincts for what to escalate and what to absorb.
• Scientific and technical curiosity — genuinely interested in understanding the underlying CMC work, not just the schedule around it.
• Sound judgment and discretion, with the ability to operate independently in a lean, fast-paced, growing clinical-stage biotech environment.
• Strong working proficiency with Excel, PowerPoint and SharePoint/Teams, and fluency (or fast aptitude) with timeline and dashboard tools.
• Flexible with an “all-hands” mindset; willing and able to step into project management support outside CMC.
• 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!