Clinical Development Lead, Pulmovant

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer clinical and scientific expertise for study design, protocol concepts, development, statistical analysis plans, and reporting.

• Ensure medical strategic oversight and accountability for study designs, protocol formulation, and regulatory documentation in collaboration with cross-functional teams.

• Lead the execution and management of clinical studies, particularly the Phase 3 trial, which includes study delivery, recruitment, site activation, data review and analysis, and reporting while adhering to GCP and regulatory standards.

• Monitor the therapeutic and regulatory environment, providing strategic guidance for program development.

• Collaborate with opinion leaders, Principal Investigators, internal clinicians, translational sciences, and clinical operations teams.

• Attend and deliver presentations at investigator meetings and site initiation visits.

• Contribute to the creation of protocols, Clinical Study Reports, Annual Reports, safety reports, Health Authority pre-meeting packages, Investigator Brochures, and periodic clinical reports.

• Prepare abstracts, manuscripts, presentations, and the clinical sections of regulatory documents.

• Maintain up-to-date knowledge of ICH-GCP, external regulations, and procedures.

• Act as the primary source for medical accountability and oversight, serving as a medical lead, liaison between investigators and internal study teams, and relationship manager for key opinion leaders and Health Authorities.

⛳️ Requirements

• An MD/DO degree or equivalent is mandatory.

• A minimum of 5–7 years of experience in conducting clinical research trials within the biopharmaceutical sector is required.

• Practical experience in protocol development and clinical trial monitoring is essential.

• Excellent written and verbal communication skills are necessary.

• A willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities is crucial.

• Ability to effectively deliver presentations at conferences, advisory meetings, and other public forums is required.

• A commitment to educate and mentor internal and external colleagues and collaborators is expected.

• A robust capability to work within, lead, and inspire a cross-functional matrixed team is essential.

• Scientific acumen and communication skills that can influence and collaborate with scientific, regulatory, and business leaders are necessary.

• Strong strategic, clinical, technical, operational, and ethical judgment with unwavering integrity is required.

• Willingness to travel as needed is a must.

• Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in cardiopulmonary/respiratory medicine is highly desirable.

• Experience in late-phase clinical development is preferred.

• Familiarity with U.S. and European Health Authority interactions and the submission of clinical regulatory documents is advantageous.

🏝️ Benefits

• Comprehensive health insurance coverage.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and continuing education.

• Flexible work environment with potential for remote work.

• Generous paid time off and holiday schedule.