Role Description
Pulmovant is seeking a highly motivated hands-on physician leader who will be responsible for the design and execution of clinical trial activities to support the development of mosliciguat, including:
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Study design
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Protocol development
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Execution and data interpretation
The candidate will be the primary source of medical accountability and oversight for clinical trials and will serve as a medical lead. Responsibilities include:
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Liaising between investigators and the internal study team
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Maintaining established relationships with key opinion leaders and Health Authorities
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Leading the execution of the Phase 3 trial
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Indication lead activities for additional indications as the program develops
Qualifications
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MD/DO degree or equivalent is required
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Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in drug development in cardiopulmonary/respiratory medicine is highly desirable
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Minimum of 5 - 7 years experience conducting clinical research trials in the biopharmaceutical industry, ideally with late phase experience
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Hands-on experience in protocol development and clinical trial monitoring
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Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable
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Strong written and verbal communication skills
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Willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities
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Ability to effectively give presentations at conferences, advisory meetings, and other public forums
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Willingness to educate and mentor internal and external colleagues and collaborators
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Engaged, hands-on, independent, and goal-oriented mentality
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Self-motivated with strong commitment to follow up on tasks and action items
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Organizational, analytical, and problem-solving skills
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Strong ability to work within and lead a cross-functional matrixed team
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Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity
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Ability to travel as needed
Requirements
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Remain current on the therapeutic landscape, including regulatory in the relevant therapeutic areas
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Collaborate with external opinion leaders and Principal Investigators
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Maintain current awareness of development and regulatory issues related to competitive compounds
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Attend and present at investigator meetings and site initiation visits as applicable
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Provide clinical leadership and contribute to the preparation of protocols, Clinical Study Reports, and other safety reports
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Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings
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Maintain knowledge of ICH-GCP, external regulations, and procedures
Benefits
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Pulmovant provides equal employment opportunities to all employees and applicants for employment
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Prohibits discrimination and harassment of any type