Jobs 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.

Leads global regulatory strategy and execution for Pulmovant’s clinical-stage pharmaceutical program. Oversees IND, CTA, NDA, BLA, and MAA submissions; coordinates FDA and international health-authority interactions; guides cross-functional teams, CROs, and advisors; manages regulatory commitments, responses, labeling, compliance, and submission timelines. The role also supports due diligence, regulatory intelligence, internal procedures, budgeting, and preparation for health-authority meetings.

Leads biostatistical strategy for Pulmovant’s Phase 3 PHrontier clinical trial, including protocol design, statistical analysis plans, sample size calculations, interim analyses, regulatory submissions, and health authority responses. Oversees CRO biostatistics deliverables, collaborates on data management and CRF design, presents results to stakeholders, supports inspection readiness, and mentors junior staff. Requires extensive clinical drug development experience, Phase 3 expertise, and proficiency in SAS and/or R.

Supports pharmacovigilance and drug safety activities across clinical trials, including case management, SAE reporting, signal detection, aggregate safety reporting, risk management, and regulatory compliance. Oversees safety vendors and CROs, maintains PV systems and documentation, supports safety committees, audits, inspections, and health authority interactions. Partners cross-functionally with clinical, regulatory, and medical teams while mentoring junior staff and contributing to PV strategy.

Leads clinical development for mosliciguat, with primary medical accountability for Phase 3 trial design, protocol development, execution, data interpretation, regulatory documentation, and health authority interactions. Collaborates with investigators, key opinion leaders, clinical operations, regulatory teams, and cross-functional partners. Supports study recruitment, site activation, safety and quality oversight, clinical reporting, publications, presentations, and potential expansion into additional indications.

Leads global clinical supply planning and execution, including investigational product packaging, labeling, inventory, forecasting, logistics, distribution, vendor management, and regulatory compliance. Oversees contract manufacturers, mentors clinical supply managers, develops procedures and pharmacy manuals, supports submissions and inspections, and manages supply-related risks and business continuity for clinical trials.

The Associate Director of Regulatory Affairs supports global regulatory strategy and execution for clinical development and product registration. Responsibilities include preparing and reviewing IND, CTA, BLA, NDA, and MAA submissions; coordinating with health authorities, CROs, and cross-functional teams; managing regulatory deliverables, responses, briefing documents, and compliance activities; monitoring regulatory intelligence; and supporting policies, budgets, and timely submissions across global programs.