Global Chief Medical Officer

About This Role

This role involves leading the global clinical development strategy and execution for the company's cell therapy pipeline, overseeing clinical trials from Phase I to commercialization, and ensuring regulatory compliance across multiple geographies. The Global CMO will serve as a key clinical resource in interactions with regulatory agencies and provide strategic direction for clinical teams in the US and China.

Responsibilities

• Lead the global clinical development strategy and execution for the company’s pipeline, ensuring alignment with corporate goals, market needs, and scientific advancements
• Oversee clinical trial design and execution, including Phase I-IV studies, for cell therapy products
• Provide strategic direction and operational management for clinical teams across the US and China, including medical, scientific, pharmacovigilance, clinical operations, site management, biometrics, and data integrity
• Act as a key clinical resource in interactions with regulatory agencies (FDA, EMA, NMPA), ensuring adherence to regulatory requirements in both US and China
• Build and lead a high-performing, cross-functional clinical development team across multiple geographies
• Ensure the company’s clinical programs are in compliance with regulatory requirements and industry standards (GxP, ICH, etc.)
• Guide the preparation and submission of Investigational New Drug (IND) applications, clinical trial applications (CTA), and other regulatory submissions
• Oversee the design, conduct, and interpretation of clinical trials, ensuring high-quality data collection, monitoring, and reporting
• Lead the review and analysis of clinical trial data to drive decision-making and ensure optimal clinical outcomes
• Be a thought leader in cell and gene therapy, providing clinical insights into scientific developments, competitive landscapes, and emerging technologies

Requirements

• MD or MD/PhD
• Specialization in oncology, immunology, hematology, or a related field
• 15+ years of experience in clinical development, with a significant portion in cell and gene therapy or advanced biologics
• Experienced in both early and late-stage development
• Strong track record of leading successful clinical programs from Phase I through to commercialization in both US and Chinese markets
• Deep knowledge of clinical trial design, regulatory requirements, and GxP compliance (FDA, EMA, NMPA)
• Direct leadership experience in establishing and leading complex global clinical operations
• Demonstrated ability to develop and manage global development budgets
• Strong global regulatory experience, including preparation and submission of CTAs and INDs
• Previous experience serving in a CMO or senior medical leadership role within a commercial-stage biopharma company
• Proven ability to lead cross-functional teams across diverse geographical regions
• Exceptional communication skills
• Ability to manage complex, multinational clinical trials and cross-border teams
• Strategic mindset combined with strong operational expertise in clinical trials
• Proven experience navigating global regulatory environments
• Strong leadership skills and a collaborative approach
• Fluency in English

Qualifications

• MD or MD/PhD with specialization in oncology, immunology, hematology, or a related field
• 15+ years of experience in clinical development, with a significant portion spent in cell and gene therapy or advanced biologics; experienced and accomplished in both early and late-stage development with a strong track record of leading successful clinical programs from Phase I through to commercialization

Nice to Have

• Additional training in clinical pharmacology, cell and gene therapy, or molecular biology
• Product development experience in both pharma and biotech companies
• Experience working in a publicly traded company with business acumen
• Experience with clinical development in China
• Experience in cell-based therapies such as CAR-T, stem cell therapies, or gene therapies
• Proficiency in Mandarin

Benefits