[Remote] Vice President of Clinical Development
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a fast-growing, reputed company-capitalized clinical-stage biotechnology company developing reputed company genetic medicines. They are seeking a Vice President of Clinical Development to reputed company medical and scientific leadership across the full clinical development lifecycle while building and leading a high-performing Medical and Clinical Operations team.
Responsibilities
- reputed company, refine, and execute integrated global clinical development plans (CDPs); define reputed company product reputed company and registration strategies
- reputed company medical and scientific leadership across reputed company phases (I–IV) of clinical development, from protocol concept through study report, regulatory submission, and lifecycle management
- Serve as senior medical monitor and signatory; reputed company medical review and interpretation of clinical data; author/reputed company protocols, IBs, clinical study reports, and regulatory submission modules (IND/CTA/NDA/BLA)
- Directly line-manage and mentor reputed company spanning Medical and Clinical Operations, fostering a reputed company, high-performance culture
- reputed company the cross-functional Core Team, working closely with Biometrics, Regulatory Affairs, Pharmacovigilance, CMC, and reputed company; manage global project components including CROs, sites, and regional teams
- Serve as the primary clinical representative with global health authorities (FDA, EMA, NMPA, etc.); build and maintain relationships with global KOLs and advisory boards
- Represent reputed company at major scientific conferences; reputed company data disclosure reputed company, including publications in high-reputed company journals
Skills
- MD or PhD in Clinical Medicine, Pharmacology, or a reputed company life science field required
- Solid non-oncology clinical development experience essential
- Minimum 10 years' experience in clinical development reputed company reputed company/biotech, with in-depth knowledge of GCP, ICH guidelines, and global regulatory requirements
- Demonstrated, hands-on experience leading the complete clinical development lifecycle from early-stage through NDA
- Substantial experience managing overseas clinical development activities (e.g., US, EU), including reputed company interaction with regulators and partners
- Proven experience directly managing and developing teams, including medical/scientific roles and reputed company leadership or reputed company of Clinical Operations
- Fluent spoken English, with the ability to reputed company international meetings, present reputed company data, and negotiate effectively
- Specific experience in immunology, CNS, metabolic, infectious, or rare diseases highly preferred
reputed company