Legend Biotech US
Sr. Director/Executive Director, Head of Translational Research
Legend Biotech US, Trenton, New Jersey, United States,
Company Information
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 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
Sr. Director/Executive Director, Head of Translational Research
as part of the
Research & Development
team based in
Somerset, NJ.
Role Overview
The individual will lead the translational sciences group to provide translational biomarker support for Legend pipeline development. The ideal candidate will have in-depth knowledge in immunology and tumor biology. Experience in cell or gene therapy development is preferred. He/she is responsible for the 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 teams to develop mechanism of action hypotheses and identify key characteristics of cell therapy products.
Key Responsibilities
Lead the 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 investigations, develop MOA hypotheses, and identify key characteristics relevant to efficacy and treatment failure.
Work closely with clinical and regulatory teams on 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 a related field.
At least 15 years of relevant work experience, including a minimum of 10 years of experience in the 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.
Language: English.
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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 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
Sr. Director/Executive Director, Head of Translational Research
as part of the
Research & Development
team based in
Somerset, NJ.
Role Overview
The individual will lead the translational sciences group to provide translational biomarker support for Legend pipeline development. The ideal candidate will have in-depth knowledge in immunology and tumor biology. Experience in cell or gene therapy development is preferred. He/she is responsible for the 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 teams to develop mechanism of action hypotheses and identify key characteristics of cell therapy products.
Key Responsibilities
Lead the 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 investigations, develop MOA hypotheses, and identify key characteristics relevant to efficacy and treatment failure.
Work closely with clinical and regulatory teams on 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 a related field.
At least 15 years of relevant work experience, including a minimum of 10 years of experience in the 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.
Language: English.
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