Hiring: Vice President Clinical Development Company: Avetix Bio Location: United States Job Posted Time: 2026-09-09 22:39:31 Target Skills & Keywords : GCP About the job Experience: •10 years of experience in clinical development within the pharmaceutical or biotechnology industry. In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements. Strong strategic thinking, problem-solving, and analytical skills. •Minimum 10 years of experience in clinical development within the pharmaceutical or biotechnology industry. In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements. Strong strategic thinking, problem-solving, and analytical skills. Required Skills: •Develop, refine, and execute integrated global clinical development plans (CDPs) for assigned programs. Define target product profiles and registration strategies. •Provide medical and scientific leadership across all phases (I-IV) of clinical development. Ensure timely 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/oversee key documents: protocols, IBs, clinical study reports, and regulatory submission modules (IND/CTA/NDA/BLA). •Directly line-manage and mentor a team of Medical and Clinical Operations. Foster a collaborative, high-performance culture. Provide strategic direction and oversight to the team, ensuring close functional alignment. •Lead the cross-functional Core Team. Collaborate effectively with Biometrics, Regulatory Affairs, Pharmacovigilance, CMC, and Commercial. 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. Qualifications: •MD or PhD in Clinical Medicine, Pharmacology, or a related life science field is required. •Solid experience in non-oncology clinical development is essential. Specific experience in immunology, CNS, metabolic, infectious, or rare diseases is highly preferred. •Minimum 10 years of experience in clinical development within 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 direct interaction with the regulators and partners. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!