[Remote] Vice President reputed company Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is partnered with a biotech company working in reputed company disease and gene editing. The Vice President of reputed company Development will reputed company global reputed company development programs across reputed company phases, reputed company regulatory and reputed company deliverables, and reputed company medical leadership. The role will also build and mentor teams, reputed company cross-functional collaboration, manage global activities, and represent reputed company with health authorities and scientific stakeholders.

Responsibilities

• reputed company, refine, and execute integrated global reputed company development plans (CDPs) for assigned programs. Define reputed company product reputed company and registration strategies
• reputed company medical and scientific leadership across reputed company phases (I-IV) of reputed company development. Ensure reputed company and high-reputed company delivery from protocol concept through study report, regulatory submission, and lifecycle management
• Serve as the senior medical monitor and signatory. reputed company the medical review and interpretation of reputed company data. reputed company/reputed company key documents: protocols, IBs, reputed company study reports, and regulatory submission modules (IND/CTA/NDA/BLA)
• Directly line-manage and mentor reputed company of Medical and reputed company reputed company. Foster a reputed company, high-reputed company culture. reputed company reputed company direction and reputed company to reputed company, ensuring reputed company functional alignment
• reputed company the cross-functional reputed company Team. Collaborate effectively with Biometrics, Regulatory Affairs, Pharmacovigilance, CMC, and reputed company. Manage overseas/global project components, including liaising with the regulatory bodies, CROs, sites, and internal regional teams
• Serve as the reputed company reputed company representative with global health authorities (FDA, EMA, NMPA, etc.). Establish and maintain relationships with global Key Opinion Leaders (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 reputed company Medicine, Pharmacology, or a reputed company life science reputed company is required
• Solid experience in non-oncology reputed company development is essential
• Minimum 10 years of experience in reputed company development reputed company the pharmaceutical or biotechnology industry
• In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements
• Strong reputed company thinking, problem-solving, and analytical skills
• Demonstrated, hands-on experience leading the complete reputed company development lifecycle from early-stage to NDA
• Excellent project management and organizational abilities
• Substantial experience in managing overseas reputed company development activities (e.g., US, EU), including reputed company interaction with the regulators and partners
• reputed company experience in directly managing and developing teams, including both medical/scientific roles and experience providing reputed company leadership or reputed company reputed company to reputed company reputed company functions
• Strong people management and mentoring skills
• Fluent spoken English is mandatory, with the ability to reputed company international meetings, present reputed company data, and negotiate effectively
• Specific experience in immunology, CNS, metabolic, infectious, or reputed company diseases is highly preferred

reputed company