Sr. Director of Clinical Translational Biomarker Lead

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.

 

Legend Biotech is seeking Sr. Director of Clinical Translational Biomarker Lead as part of the Translational Science team based in Somerset, NJ. 

Role Overview

Lead and advance the biomarker strategy for Carvykti throughout clinical lifecycle, from late-stage trials, regulatory filings and post marketing commitment.  Collaborate across clinical, medical affairs, pharmacovigilance, commercial, and regulatory functions to ensure data-driven insights for patient stratification, mechanistic understanding, safety mitigation, and regulatory success. Enhance patient selection and risk stratification to strengthen real-world adoption and clinical impact.

Key Responsibilities  

• Define and execute the biomarker and translational strategy for Carvykti across late clinical development, including post-marketing phases
• Drive biomarker integration into clinical protocols, data analysis plans, and regulatory submission packages if necessary
• Lead development and implementation of additional biomarker assays if necessary
• Collaborate with cross-functional teams, Clinical Development, Data Science, Regulatory, pharmacovigilance, Medical Affairs, to design and align on biomarker strategy
• Synthesize biomarker, safety readout and clinical data to guide strategic decisions, enhance patient selection, optimize dosing and safety monitoring
• Engage with KOLs and external collaborators to discuss biomarker rationale and relevance to clinical outcomes and patient management
• The person will define the biomarker and translational strategy for Carvykti across late clinical development, including post-marketing phases and accountable for budget on all translational work in JNJ collaboration

Requirements

• PhD in biology, immunology, or related field
• 10+ years of experience in biomarker strategy within oncology, ideally involving CAR-T, cellular therapies, TCE or hematologic malignancies
• Demonstrated expertise in developing and managing biomarkers used for patient stratification.
• Comfortable working in matrixed environments, managing external partnerships, and navigating complex datasets. Strong data analysis skills to correlate biomarker readout to clinical outcomes
• Prior exposure to CAR-T biomarker programs, preferably in multiple myeloma.
• Advanced Proficiency of excel
• Proficiency in outlook
• Proficiency in teams

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The anticipated base pay range is:$216,186—$283,745 USD

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 vest fully on day one. Equity and stock options are available to employees in eligible roles, we 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 sav