Lead clinical development strategy and execution for pulmonary therapeutics, design and oversee protocols and study documents, engage investigators and CROs, analyze safety and efficacy data, and manage scientific publications and communications across cross-functional teams.

Manage regulatory documentation, publishing, QC, archiving, and submissions (IND/NDA/BLA) using Veeva RIM and DocuBridge. Implement SOPs, ensure timely, validated submissions, and collaborate with regulatory, CMC, and project teams. Hands-on formatting and operational leadership required.

Manage day-to-day clinical study operations including timelines, enrollment metrics, TMF QC, monitoring oversight, vendor/CRO management, study planning and system setup, and ensure GCP/ICH compliance.

Provide global regulatory strategy and support for clinical development and approval of pulmonary therapies. Prepare and review regulatory submissions, liaise with health authorities, guide cross-functional teams, track commitments, and contribute to labeling, policy, and due diligence.

Lead accounting functions including monthly/annual financial reporting, clinical trial accruals, budgeting/forecasting, internal controls, audit coordination, and manage an accounting team to support strategic decision-making.