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Tbwa Chiat/Day Inc

Director, Head of Translational Research

Tbwa Chiat/Day Inc, Trenton, New Jersey, United States,


Director, Head of Translational Research

Somerset, New Jersey, United StatesCompany InformationLegend 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 and natural killer (NK) cell-based immunotherapy.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) in 2017. 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

Director, Head of Translational Research

as part of the

Research & Development

team based in

Somerset, NJ.Role OverviewThe individual will lead the translational sciences group to provide translational biomarker support for Legend pipeline development. Ideal candidate will have in-depth knowledge in immunology and tumor biology. Experiences in cell or gene therapy development is preferred. He/she is responsible for design, delivery, and execution of biomarker and translational strategies including patient selection, pharmacodynamic endpoints, target engagement and pharmacodynamics and safety biomarkers. The individual will work closely with preclinical, CMC and clinical development team to develop mechanism of action hypotheses and identify key characteristics of cell therapy products.Key ResponsibilitiesLead translational team, and provide preclinical and clinical translational support for Legend pipeline development.Coach and lead translational representatives in cross functional development teams; Collaborate with discovery, preclinical development, CMC and clinical teams to accelerate the product pipeline.Establish translational biomarker strategy in alignment with clinical development objectives; Lead translational safety investigation, develop MOA hypothesis and identify key characteristics relevant to efficacy and treatment failure.Work closely with clinical and regulatory teams in investigator brochures, IND applications, clinical protocols, and other clinical and regulatory documents when appropriate.Accountable for patient selection strategies, CDx development, approval and implementation.Provide oversight and management to CROs and academic collaborations.Requirements

PhD or MD in biology, immunology, biochemistry or related field.At least 15 years of relevant work experience, including a minimum of 10 years of experience in pharmaceutical or biotech industry. Experience in cell therapy clinical development is preferred. Knowledge and experience in CDx development are a plus.In depth Knowledge of immunology and tumor biology.Strong background in clinical biomarker analysis, research tools, technology and assay platforms.Excellent communication and writing skills.Ability to work effectively and collaboratively in cross functional teams.

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