A company is looking for a Clinical Research Medical Director specializing in Rare Disease, offering a remote position in the United States to oversee Phase 3 clinical studies and support regulatory filings.
Key Responsibilities
Contribute to clinical development executional activities for Phase 3 studies, including data review and CRO interactions
Support submission activities for regulatory filings and contribute to planning future studies in the rare disease area
Provide clinical/scientific input into development programs, safety and regulatory interactions, and author/review clinical study reports and regulatory submissions
Required Qualifications and Education
MD or DO degree from an accredited medical school
2 years of clinical research experience and/or basic science research
Preferred: Accredited residency in relevant sub-specialty, board certified or equivalent
Preferred: Three (3) or more years of clinical development experience in the biopharmaceutical industry
Preferred: Experience in development lifecycle management and involvement in filing activities for regulatory approvals