Teams at Pulmovant

Manage supporting PH-ILD drug development studies, including Phase 1, biomarker, population PK, and nonclinical programs. Lead integrated planning, timelines, budgets, risks, issues, documentation, metrics, and stakeholder communication across internal teams and external partners. Coordinate cross-functional development activities and support program management processes, reporting, and governance while ensuring deliverables meet quality and regulatory expectations.

Lead statistical programming for Phase 2b/3 clinical studies and regulatory submissions. Develop and validate SAS and R programs, CDISC-compliant SDTM and ADaM datasets, TLFs, define.xml files, Reviewers’ Guides, and submission packages. Coordinate with biostatistics, data management, regulatory, clinical, and medical writing teams; oversee CRO deliverables, timelines, quality controls, SOPs, and process improvements. Mentor junior programmers and potentially manage direct reports at the Senior Manager level.

Leads global clinical supply execution for pharmaceutical trials, including demand forecasting, inventory and resupply planning, clinical packaging, labeling, distribution, shipping, and vendor management. Partners with Clinical Operations, CMC, Quality, Regulatory, CROs, and trial sites to ensure timely investigational product delivery and compliance with cGxP requirements. Supports IXRS development, risk mitigation, inspection readiness, and global clinical inventory systems.