Legend Biotech is seeking a Sr. Principal Scientist/Associate Director of Clinical Pharmacology as part of the Research and Early Development team based in Somerset, NJ.
Role Overview
The position functions as the leader of clinical pharmacology to support cell therapy drug development (prior experience with gene and cell therapy products preferred).
Key Responsibilities
- Function as clinical pharmacology representative in the project team and support clinical pharmacology-related activities in clinical studies, including protocol design, study implementation, data analysis, reports writing and regulatory submissions, etc.
- Ensure that clinical pharmacology strategy is developed, aligned with cross-function team, endorsed and executed to support the pipeline development
- Coordinate and monitor clinical pharmacology data to ensure all execution is in line with departmental strategy, in compliance with regulatory and legal requirements, and company standard operating procedures.
- Conduct pharmacokinetic (PK)/pharmacodynamic (PD) and dose-exposure-response analysis to support dose selection, trial design, internal decision-making, regulatory submissions, and published articles.
- Provide advice for preclinical stage projects to optimize in vitro and preclinical data, support projects to advance clinical development and submit new drug applications.
- Writing clinical pharmacology-related documents, oral communication, and presentation, etc.
- Key Relationships: R&D, Preclinical development, Clinical, CMC and regulatory
Requirements
- PhD/Pharm D in pharmaceutical science, pharmacokinetics, clinical pharmacology, quantitative pharmacology, biomedical engineering, Immunology or related field
- 4-5+ years working experience of clinical pharmacology in pharmaceutical companies or CRO companies
- Capability requirements:
- Have strong execution ability;
- Strong independent scientific research ability, logical thinking, and coordination/problem-solving skills;
- Have clear written and oral communication skills;
- Have a good team spirit;
- Have strong execution ability;
- Skill requirements:
- Deep understanding of PK, PD, PK/PD, and/or Translational Medicine and the role of clinical pharmacology in clinical trials and drug development.
- Demonstrated ability and experience in apply modelling and simulation approaches to enable rational and efficient preclinical and clinical drug development.
- Familiar with regulatory requirements and guidelines of clinical pharmacology.
- Familiar with pharmacokinetic software (such as Phoenix WinNonlin); knowledge and skills of PK/PD modelling and simulation software (such as NONMEM, R, etc.) are a plus.
- Good project management skills, and the ability to collaborate with other departments and manage with internal and external partners.
- Demonstrated strong level of expertise and scientific reputation through multiple publications and presentations.
- Deep understanding of PK, PD, PK/PD, and/or Translational Medicine and the role of clinical pharmacology in clinical trials and drug development.
- Other requirements:
- Good personality, honest and trustworthy;
- Physically and mentally healthy, love life;
- Good personality, honest and trustworthy;
- 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.