Global Chief Medical Officer jobs in United States
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Legend Biotech · 3 months ago

Global Chief Medical Officer

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. They are seeking a Global Chief Medical Officer to lead the clinical development strategy and oversee clinical programs, ensuring safety, efficacy, and regulatory compliance of innovative therapies.

BiotechnologyHealth CareLife ScienceOncologyTherapeutics
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H1B Sponsor Likelynote

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
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
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
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
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
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

Qualification

Clinical Development StrategyCellGene TherapyRegulatory ComplianceClinical Trial DesignOncology SpecializationGlobal Regulatory ExperienceLeadership ExperienceCross-Functional Team LeadershipFluency in EnglishMandarinExceptional CommunicationStrategic Mindset

Required

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
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)
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

Preferred

Additional training in clinical pharmacology, cell and gene therapy, or molecular biology
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
Experience in cell-based therapies such as CAR-T, stem cell therapies, or gene therapies is highly desirable
Proficiency in Mandarin is a plus

Benefits

Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs

Company

Legend Biotech

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Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.

H1B Sponsorship

Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)

Funding

Current Stage
Public Company
Total Funding
$750.45M
2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO

Leadership Team

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Carlos Santos
Chief Financial Officer
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Alan Bash
President, CARVYKTI
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Company data provided by crunchbase