Clinical Development Lead (MD)
New
P
PulmovantBiotechnology
Remote, USFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5 - 7 years
- Required Skills
- GCP
Requirements
- MD/DO degree or equivalent.
- Board Certification or Board Eligibility in internal medicine.
- Subspecialty training or drug development experience in cardiopulmonary or respiratory medicine (highly desirable).
- Minimum 5-7 years of experience conducting clinical research trials in the biopharmaceutical industry.
- Direct experience in protocol development and clinical trial monitoring.
- Strong written and verbal communication skills for engaging with investigators, regulatory authorities, and key opinion leaders.
- Demonstrated ability to lead and motivate cross-functional matrixed teams.
- Ability to travel as needed.
- Experience with US and European Health Authority interactions and regulatory document submissions (desirable).
- Commitment to maintaining knowledge of ICH-GCP and external regulatory procedures.
Responsibilities
- Provide clinical and scientific input to study design, protocol development, statistical analysis plans, and reporting.
- Maintain medical strategic oversight and accountability for clinical trial design and regulatory documents.
- Provide clinical leadership for trial execution, including recruitment, site activation, and data management in compliance with GCP and regulatory standards.
- Engage with external opinion leaders and investigators to ensure successful study design and implementation.
- Monitor the competitive landscape and regulatory environment to guide strategic program direction.
- Prepare clinical sections of regulatory documents, including Investigator Brochures, IND sections, and Clinical Study Reports.
- Represent the company at investigator meetings, site initiation visits, and scientific conferences.
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