What are the responsibilities and job description for the Clinical Research IIT Program Director position at Shanghai Sailybio Biotechnology Co., Ltd?
Key Responsibilities:
- Program Strategy & Development: Design and implement the strategic framework, SOPs, and management processes for a global IIT program focused on supporting overseas sponsors.
- End-to-End Project Leadership: Oversee the entire IIT lifecycle, including feasibility assessment, proposal and protocol development, site selection/initiation, vendor management, monitoring, data analysis, and final reporting/publication support.
- Client & Stakeholder Management: Serve as the primary point of contact for overseas sponsors (e.g., U.S./European biotechs). Manage relationships with key investigators, research sites, CROs, and internal cross-functional teams in China.
- Operational Excellence: Ensure all IIT activities are conducted in compliance with ICH-GCP guidelines, local Chinese regulatory requirements, and sponsor-specific protocols. Proactively identify and mitigate project risks.
- Team Building & Oversight: Build and mentor a future team of clinical operations professionals dedicated to IIT management. Manage timelines, budgets, and quality metrics for all assigned studies.
- Market Intelligence: Provide critical insights on the feasibility, advantages, and operational landscape of conducting overseas IITs in China, informing our business development strategy.
Qualifications:
- Advanced degree (M.S., Ph.D., M.D., or Pharm.D.) in a life science or medical field.
- Minimum of 10 years of experience in clinical research, with at least 7 years in a leadership role directly managing IITs/ISTs (Investigator-Sponsored Trials).
- Must have: Proven, hands-on experience managing the full lifecycle of IITs from concept to completion.
- Deep understanding of ICH-GCP and FDA regulations. Experience with NMPA (China) regulations is a strong plus.
- Direct experience working with or for pharmaceutical companies, biotechs, or major academic research centers on the sponsor side of IITs.
- Excellent business acumen and communication skills, with the ability to engage confidently with senior-level external stakeholders and internal leadership.
- Strategic thinker with the ability to build processes from the ground up in a new business area.
职位类型：全职, 佣金制
薪资： $64,614.47至$77,815.27（每年 ）
Work Location: 现场办公
Salary : $64,614 - $77,815