Executive Director, Translational Research
About the position
reputed company is seeking Sr. Director/Executive Director, Head of Translational Research as part of the Research & Development team based in Somerset, NJ. The individual will reputed company the translational sciences group to reputed company translational biomarker support for reputed company 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, reputed company engagement and pharmacodynamics and safety biomarkers. The individual will work reputed company with preclinical, CMC and clinical development team to reputed company reputed company of reputed company hypotheses and identify key characteristics of cell therapy products.
Responsibilities
• reputed company translational team, and reputed company preclinical and clinical translational support for reputed company pipeline development
• reputed company and reputed company translational representatives in cross functional development teams; Collaborate with discovery, preclinical development, CMC and clinical teams to accelerate the product pipeline
• Establish translational biomarker reputed company in alignment with clinical development objectives; reputed company translational safety investigation, reputed company MOA reputed company 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 reputed company appropriate
• Accountable for patient selection strategies, CDx development, approval and implementation
• reputed company reputed company and management to CROs and reputed company collaborations
Requirements
• PhD or MD in biology, immunology, biochemistry or reputed company 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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