BioSpace
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across diverse technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. We leverage these innovative technologies in pursuit of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialise ciltacabtagene autolecuel (cilta‑cel), advancing an immunotherapy for multiple myeloma.
Role Overview Global Chief Medical Officer
(CMO) is a senior clinical development leader within the
Clinical Development
team based in
Somerset, NJ . The CMO will oversee the global clinical development strategy, ensuring safety, efficacy, and regulatory compliance of the company’s innovative therapies and shaping the clinical vision for the pipeline across the United States and China.
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 programmes 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 teams 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 programmes, 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 programmes 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.
Benefits We are committed to creating a workplace where employees can thrive—both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k) retirement plan with company match that vests fully on day one. Equity and stock options are available to employees in eligible roles. We also offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs—demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Anticipated Base Pay Range $434,828 - $570,710 USD
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
#J-18808-Ljbffr
Legend Biotech entered into a global collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialise ciltacabtagene autolecuel (cilta‑cel), advancing an immunotherapy for multiple myeloma.
Role Overview Global Chief Medical Officer
(CMO) is a senior clinical development leader within the
Clinical Development
team based in
Somerset, NJ . The CMO will oversee the global clinical development strategy, ensuring safety, efficacy, and regulatory compliance of the company’s innovative therapies and shaping the clinical vision for the pipeline across the United States and China.
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 programmes 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 teams 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 programmes, 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 programmes 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.
Benefits We are committed to creating a workplace where employees can thrive—both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best‑in‑class benefits package that supports well‑being, financial stability, and long‑term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k) retirement plan with company match that vests fully on day one. Equity and stock options are available to employees in eligible roles. We also offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We provide commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs—demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Anticipated Base Pay Range $434,828 - $570,710 USD
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug‑free workplace.
#J-18808-Ljbffr