Legend Biotech US
Global Chief Medical Officer
Somerset, New Jersey, United States · Exec · Full-time
Sponsorship not specified$435k-$571kDetected 26 days ago
ComplianceBusiness DevelopmentClinical TrialsPharmacologyFDA RegulatoryCRISPRMolecular BiologyPharmacovigilanceResearchAnimal StudiesLeadershipCommunicationCollaborationMentoringPublic SpeakingGxPRegulatory Affairs
About the role
- By combining deep scientific expertise with advanced manufacturing and global execution capabilities, Legend Biotech aims to change the way the world treats disease and to make cutting-edge cell therapies broadly accessible to patients.
- Legend Biotech is at the forefront of cell therapy research and development.
- This role is pivotal in overseeing the global clinical development strategy, ensuring the safety, efficacy, and regulatory compliance of the company's innovative therapies, and shaping the clinical vision for the company's pipeline.
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.
- Build and lead a high-performing, cross-functional clinical development team across multiple geographies, fostering a culture of collaboration, excellence, and scientific rigor.
- 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
- 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.
Requirements
- 15+ years of experience in clinical development, with a significant portion spent in hematology and cell and gene therapy or advanced biologics.
- Strong track record of leading successful clinical programs from Phase I through to commercialization, ideally in both US and Chinese markets.
- Product development experience in both pharma and biotech companies is highly desirable.
- 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.
- Proven experience navigating global regulatory environments and ensuring timely and successful product approvals within budget.
Nice to have
- 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.
- Fluency in English
- proficiency in Mandarin is a plus.
Compensation
- $434,828 - $570,710 USD
Benefits
- 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.
Company info
- Legend Biotech is a global, integrated cell therapy company dedicated to discovering, developing, and manufacturing transformative therapies for patients with cancer, autoimmune, and other serious diseases.
- Ensure the company's clinical programs are in compliance with regulatory requirements and industry standards (GxP, ICH, etc.).
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