Director Clinical Operations 临床运营总监
Shanghai
Permanent
Negotiable
Clinical
PR/599944_1785513782
Director Clinical Operations 临床运营总监
Our client is a well-established clinical-stage organization within the biotechnology and life sciences sector, focused on advancing innovative therapies through early-phase clinical development. With a growing pipeline and international collaboration, the company is expanding its clinical operations leadership to support studies across key markets.
Responsibilities:
- Lead the strategy and execution of clinical programs, ensuring delivery against timelines, budget, and quality expectations
- Oversee daily clinical trial operations and ensure compliance with GCP, SOPs, and applicable regulatory requirements
- Manage and oversee CROs and external vendors to drive performance and accountability
- Partner with cross-functional teams including medical, regulatory, and development to enhance operational efficiency
- Act as the escalation point for issues related to study timelines, quality, budget, and vendor performance
- Support regulatory inspections and maintain inspection readiness across all clinical activities
- Provide regional expertise to global teams on clinical development and local regulatory processes
- Take on project management responsibilities as required, including planning, risk mitigation, and study execution
Requirements:
- Bachelor's degree in life sciences or a related field; advanced degree is advantageous
- Strong knowledge of GCP/ICH guidelines and global clinical trial regulations
- Proven experience overseeing Phase I-II clinical trials
- Demonstrated experience managing CROs and external vendors
- Ability to work effectively in a fast-paced, matrixed environment
- Strong organizational skills with the ability to manage multiple priorities
- Fluency in English; additional language skills such as Mandarin are beneficial
If you are interested, please apply with your updated CV