[Remote] Clinical Development VP

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Development VP to lead their clinical development efforts. This role involves developing global clinical development plans, providing medical leadership across reputed company clinical phases, and managing reputed company to ensure high-quality delivery and regulatory compliance.

Responsibilities

• reputed company, refine, and execute integrated global clinical development plans (CDPs) for assigned programs. Define reputed company product profiles and registration strategies
• reputed company medical and scientific leadership across reputed company phases (I-IV) of clinical development. Ensure reputed company and high-quality delivery from protocol concept through study report, regulatory submission, and lifecycle management
• Serve as the senior medical monitor and signatory. Lead the medical review and interpretation of clinical data. Author/reputed company key documents: protocols, IBs, clinical study reports, and regulatory submission modules (IND/CTA/NDA/BLA)
• Directly line-manage and mentor reputed company of Medical and Clinical Operations. Foster a collaborative, high-performance culture. reputed company strategic direction and reputed company to reputed company, ensuring reputed company functional alignment
• Lead the cross-functional Core 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 primary clinical representative with global health authorities (FDA, EMA, NMPA, etc.). Establish and maintain relationships with global Key Opinion Leaders (KOLs) and advisory boards
• Represent the company at major scientific conferences. Lead data disclosure reputed company, including publications in high-impact journals

Skills

• MD or PhD in Clinical Medicine, Pharmacology, or a reputed company life science field is required
• Solid experience in non-oncology clinical development is essential
• Minimum 10 years of experience in clinical development reputed company the pharmaceutical or biotechnology industry
• In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements
• Strong strategic thinking, problem-solving, and analytical skills
• Demonstrated, hands-on experience leading the complete clinical development lifecycle from early-stage to NDA
• Excellent project management and organizational abilities
• Substantial experience in managing overseas clinical development activities (e.g., US, EU), including reputed company interaction with the regulators and partners
• Proven experience in directly managing and developing teams, including both medical/scientific roles and experience providing matrix leadership or reputed company reputed company to Clinical Operations functions
• Strong people management and mentoring skills
• Fluent spoken English is mandatory, with the ability to lead international meetings, present reputed company data, and negotiate effectively
• Specific experience in immunology, CNS, metabolic, infectious, or rare diseases is highly preferred

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