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Sr Director, Clinical Operations, China ExploR&D
Path/ Level: P5
Overview
Lilly Catalyze360 is Lilly's comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars—Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLabs—Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.
Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support—from strategic consulting to full program execution—making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines.
Job Summary
The Senior Director, Clinical Operations, China ExploR&D, serves as the clinical technical lead and strategic partner for China-based biotech collaborators, cross-functional teams, and Lilly stakeholders in advancing breakthrough biotechnology initiatives across China and the broader Asia-Pacific region. This role focuses on driving operational excellence, innovation, and strategic execution of clinical plans and trial designs for the China ExploR&D external pipeline.
The Senior Director develops and implements optimized clinical strategies tailored to the China and Asia-PAC regulatory and operational landscape by conducting comprehensive feasibility assessments using proprietary tools, local market intelligence, and regional databases. This role provides expert guidance to clinical directors and project teams from trial conception through execution, advising on optimal clinical approaches, risk mitigation strategies, and operational best-practices that drive competitive advantage and accelerate development timelines in the region.
This role may also include managing the end-to-end execution of early-phase clinical trials in China and Asia-PAC, serving as the primary point of clinical conduct for the external partners when ExploR&D have been contracted to execute clinical trials in China, working with clinical research organizations.
Key Responsibilities
Strategic Leadership & Planning
- Lead due diligence assessments for China and Asia-PAC assets, evaluating clinical feasibility and partnership fit within regional regulatory and operational context
- Conduct comprehensive feasibility assessments and develop integrated clinical operations plans and strategies for early phase trials spanning first-in-human studies through clinical proof-of-concept
- Drive operational excellence by leading clinical discussions on study design (with medical), site selection, CRO partnerships, and patient recruitment strategies optimized for China and Asia-PAC markets
Operational Execution & Problem-Solving
- Own the complete clinical trial lifecycle from planning through close-out, including protocol development support, CRO selection and onboarding, study start-up and site activation, ongoing monitoring and oversight, and quality study close-out post-completion
- Provide hands-on oversight of partnered trials conducted through CROs and vendors, rapidly diagnosing operational challenges and implementing mitigation plans to meet milestone commitments
- Serve as primary escalation point for underperforming studies, leading rescue efforts including site interventions, protocol optimization, and CRO performance management
Stakeholder Management & Collaboration
- Build and maintain strategic relationships with China-based CROs, clinical sites, regulatory consultants, and key opinion leaders to ensure operational readiness and competitive advantage
- Partner with US-based ExploR&D clinical operations leadership to align on standards, share best practices, and facilitate bidirectional knowledge exchange on China market insights and lessons learned
Innovation & Continuous Improvement
- Champion adoption and optimization of AI/ML clinical operations tools, contributing China-specific data to train models and enhance predictive accuracy for regional site performance, enrollment patterns, and clinical timelines
- Lead development of China-specific ExploR&D Clinical SOPs and guidelines, ensuring linkage to Lilly Global Standards while addressing local requirements
- Drive adoption of new Lilly and ExploR&D clinical capabilities to enhance portfolio delivery and operational efficiency
Team Development
- Recruit, manage, develop, and mentor clinical operations personnel, fostering high-performance culture and building regional organizational capability
- Partner with US-based ExploR&D clinical operations leadership to align on standards, share best practices, and facilitate bidirectional knowledge exchange on China market insights and lessons learned
Education:
- Bachelor's degree in a science or related field from an accredited college or university
- Advanced degrees and/or additional degrees in life sciences, medicine, public health, or MBA preferred
Experience:
- 10+ years work experience directly managing clinical studies in China with emphasis on early phase trials and outsourced clinical operations
- Demonstrated experience working with Chinese biotech companies and navigating China's evolving regulatory landscape
Required Skills:
- Expert in early phase clinical operations with deep knowledge of China regulatory requirements and clinical trial ecosystem
- Extensive experience implementing and managing clinical trials in China, including IND submissions to NMPA/CDE and working within China's evolving regulatory framework
- Native or fluent proficiency in Mandarin (written and spoken) with strong English communication skills for global collaboration
- Deep understanding of China's clinical research landscape, including site networks, CRO capabilities, patient recruitment dynamics, and regional differences across China
- Strong leadership abilities, strategic thinking, and entrepreneurial mindset with ability to operate effectively in a dynamic, fast-paced biotech environment
- Demonstrates success in clinical planning development, clinical feasibility assessments, and strategic vendor management specific to China market
- Proven track record troubleshooting and recovering challenged clinical trials, with ability to quickly assess root causes and implement effective corrective actions in the China context
- Strong cross-cultural communication and influence skills with experience navigating complex stakeholder environments and building consensus across Chinese and international teams
- Established network of relationships with China CROs, clinical sites, regulatory consultants, and industry thought leaders
Additional Skills/Preferences
- Experience with global clinical development programs involving both China and international sites
- Knowledge of Asia-PAC regulatory requirements beyond China (Japan, South Korea, Singapore, Australia, etc.)
- Understanding of China biotech innovation ecosystem and emerging technology platforms
Additional Information
- This position is based in Shanghai, China (alternate locations in Beijing or other major Chinese cities may be considered)
- Regular domestic travel within China required to support clinical sites, CRO partners, and biotech sponsors
- Periodic international travel to US and other global locations for strategic alignment and collaboration
- Hybrid work model: 3 days per week in Lilly China office if residing within local commuting distance
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