Description

Legend Biotech is seeking a Global Chief Medical Officer as part of the Clinical Development team based in Somerset, NJ.

Role Overview

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. The company has a vision of harnessing the power of the immune system to create durable and potentially curative treatments. 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. In pursuit of cure, the company is leveraging its integrated autologous, allogeneic and in vivo cell therapy platforms to design and deliver therapies that can reprogram immune cells to precisely target and eliminate the root cause of diseases, including cancers and autoimmune diseases.

Legend Biotech is recruiting an accomplished drug developer and a visionary organization/business leader as Global Chief Medical Officer (CMO) who will serve as the senior clinical development leader for our ongoing clinical programs and teams in both the United States and China. 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.

Reporting to President of Research and Development, the Global CMO will work closely with the executive leadership team, regulatory authorities, and key external stakeholders to lead the clinical development program from pre-clinical stages through to post-market activities. Additionally, the Global CMO will act as a strategic thought leader in the field of cell and gene therapy and provide clinical expertise in the design, execution, and interpretation of clinical trials, regulatory submissions, and product commercialization.

This position offers a unique opportunity to join a growing and innovative company at the forefront of cell and gene therapy, where the Global CMO will have the opportunity to make a profound impact on the future of medicine and improve patient outcomes globally.

Key Responsibilities

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.

Requirements

• 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.

#LI-AS1

#Li-Hybrid

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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