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. Ideal candidate will have in-depth knowledge in immunology and tumor biology. Experiences in cell ore 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 close with preclinical, CMC and clinical development team to develop mechanism of action hypotheses and identify key characteristics of cell therapy products.
Key Responsibilities
- Lead 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 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 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 law.
Legend Biotech maintains a drug-free workplace.
