Senior Director, Clinical Development Scientist, Pulmovant

Position: Senior Director, Clinical Development Scientist, Pulmovant

Position Summary:

The responsibilities are across 2 main areas: clinical development strategy and execution (75%) and leading and managing scientific publications and communications strategy and execution (25%).

The responsibilities described below may also be delegated to other team members or external collaborators (vendors, consultants) and would entail management of these individuals or entities.

Key Responsibilities:

Clinical Development

• Supporting the design and execution of key elements of the Clinical Development Plan (clinical study or studies) and associated data collection activities, within a therapeutic area.
• Contribute to the development of study concepts, protocol designs, and study essential documents by liaising with other functions and arranging external expert consultations, as needed.
• Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy.
• Collaborating on, or leading where appropriate, the preparation of clinical study related documents including protocols, charters, statistical analyses plans and summary reports, meeting presentations, publications, and clinical sections of regulatory documents.
• Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategy
• Supporting development of publications arising from studies and other relevant initiatives.
• Where appropriate, serve as the SME for identification, tran