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Pulmovant
Pulmovant
4 open remote positions
Pulmovant is a clinical-stage biotechnology company focused on developing treatments for pulmonary diseases, with a lead candidate for pulmonary hypertension associated with interstitial lung disease. As part of the Roivant family, it fosters a collaborative and innovative culture, leveraging resources to advance its pipeline.
Open Positions
Manage integrated CMC timelines and drive alignment across technical, clinical, and regulatory teams. Coordinate CDMO/CMO deliverables, budgets, and regulatory submission milestones. Facilitate cross-functional meetings, track risks and action items, and provide clear program visibility.
Project Management
CMC
Cross-functional Collaboration
Budget Tracking
Develop and validate SAS and R programs to produce CDISC-compliant datasets and TLFs for clinical studies. Serve as lead programmer on late-phase studies and regulatory submissions, ensuring high-quality, audit-ready deliverables. Collaborate with cross-functional teams and mentor junior programmers to support statistical programming standards.
SAS
R
CDISC
Regulatory Submissions
Lead late-stage drug substance process design, optimization, and scale-up across global CDMOs. Embed Quality by Design and DoE to define CPPs/CQAs and support regulatory submissions. Drive tech transfer, PPQ campaigns, and cGMP compliance for commercial readiness.
CMC
Regulatory Strategy
Manage and maintain the enterprise application portfolio, including GxP/clinical systems and general enterprise IT applications. Partner with Clinical, Regulatory, Quality, Finance, and HR teams to gather requirements and prioritize the applications roadmap. Lead system implementations, upgrades, integrations, and decommissions, coordinating computer system validation activities with Quality.
Veeva Vault
ITSM
GxP