Global Chief Medical Officer

Key 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, ensuring rigor in scientific, regulatory, and clinical outcomes.
• 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.

Team Development & Collaboration

• Build and lead a high-performing, cross-functional clinical development team across multiple geographies, fostering a culture of collaboration, excellence, and scientific rigor.
• Provide mentorship and leadership to clinical development teams, fostering professional development and ensuring alignment with organizational goals.
• Collaborate with external stakeholders, including our collaboration partner (e.g. J&J for CARVYKTI development), academic institutions, CROs, KOLs, and regulators, to support the clinical development agenda.

Regulatory & Compliance

• Ensure the company’s clinical programs are in compliance with regulatory requirements and industry standards (GxP, ICH, etc.).
• Work closely with Regulatory Affairs to interact with agencies (FDA, NMPA, EMA) and provide clinical leadership during interactions and meetings.
• Guide the preparation and submission of Investigational New Drug (IND) applications, clinical trial applications (CTA), and other regulatory submissions.

Clinical Trial Oversight & Data Review

• Oversee the design, conduct, and interpretation of clinical trials, ensuring high-quality data collection, monitoring, and reporting.
• Lead clinical operation team to deliver high-quality trial results on time and within budget.
• Lead the review and analysis of clinical trial data to drive decision-making and ensure optimal clinical outcomes.
• Ensure appropriate risk management strategies are in place for the clinical programs, including safety monitoring and adverse event reporting.

Scientific Leadership & Innovation

• Be a thought leader in cell and gene therapy, providing clinical insights into scientific developments, competitive landscapes, and emerging technologies.
• Work closely with Research, Preclinical Development, and Translation teams on discovery and preclinical pipeline.
• Lead clinical presentations and represent the company in scientific conferences, advisory boards, and medical meetings.

Commercial & Investor Relations

• Collaborate with the Commercial and Medical Affairs leadership teams to inform product launch strategies, market access, and post-marketing activities.
• Provide clinical input for business development efforts, including due diligence for new partnerships, acquisitions, and collaborations.
• Act as a key spokesperson for the company in interactions with investors, providing updates on clinical development progress and milestones.