Clinical Research IIT Program Director
Shanghai Sailybio Biotechnology Co., Ltd
64,614.47–77,815.27 a year
Behavioral Health Market Context
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Job Description
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
• 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
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
Benefits
- •薪资： $64,614.47至$77,815.27（每年 ）
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
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