Global Chief Medical Officer
- Clinical Strategy & Leadership:
- 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.
- MD or MD/PhD with specialization in oncology, immunology, hematology, or a related field; additional training in clinical pharmacology, cell and gene therapy, or molecular biology is highly desirable.
- 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. Strong track record of leading successful clinical programs from Phase I through to commercialization , ideally 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 operation to drive efficiency and quality.
- Demonstrated ability to develop and manage global development budget and deliver quality outcome on time and within budget.
- Strong global regulatory experience , including the preparation and submission of clinical trial applications and INDs.
- Previous experience serving in a CMO or senior medical leadership role within a commercial-stage biopharma company. Product development experience in both pharma and biotech companies is highly desirable.
- Experience working in a publicly traded company with business acumen and navigating the corporate and regulatory complexities associated with the commercial stage of development preferred.
- Proven ability to lead cross-functional teams across diverse geographical regions, including experience with clinical development in China .
- Exceptional communication skills , with the ability to effectively communicate complex scientific and clinical data to both internal and external stakeholders (including investors, regulators, and KOLs).
- Experience in cell-based therapies such as CAR-T, stem cell therapies, or gene therapies is highly desirable.
- Ability to manage complex, multinational clinical trials and cross-border teams and to lead global clinical operation.
- Strategic mindset combined with strong operational expertise in clinical trials to drive quality and speed of development.
- Proven experience navigating global regulatory environments and ensuring timely and successful product approvals within budget.
- Strong leadership skills and a collaborative approach to working with internal and external stakeholders.
- Fluency in English ; proficiency in Mandarin is a plus.
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