Legend Biotech is seeking a quantitative pharmacologist to lead modeling and simulation efforts for gene and cell therapy products, focusing on Quantitative Systems Pharmacology (QSP) and population Pharmacokinetics (popPK) modeling to support drug development and regulatory submissions.
Requirements
- Demonstrated expertise in QSP and popPK modeling, including proficiency with tools such as NONMEM, R, MATLAB, Monolix, etc.
- Deep understanding of PK/PD principles, translational medicine, and the role of quantitative pharmacology and model-informed drug development (MIDD) in clinical trials and drug development.
- Demonstrated ability and experience in applying modelling and simulation approaches to enable rational and efficient preclinical and clinical drug development.
- Familiar with regulatory requirements and guidelines of clinical pharmacology.
- MS/PhD/Pharm D in Pharmaceutical Sciences, Clinical Pharmacology, Applied Mathematics, Biomedical Engineering, or related quantitative discipline.
- 7+ years with MS degree or 3+ years with PhD/Pharm D degree of working experience in quantitative pharmacology or pharmacometrics in pharmaceutical companies or CRO companies.
- Prior cell and gene therapy experience preferred.
Responsibilities
- Lead QSP and popPK modeling activities across preclinical and clinical development stages.
- Play a pivotal role in shaping clinical pharmacology strategies, supporting regulatory submissions, and driving innovation in model-informed drug development (MIDD).
- Develop and apply mechanistic models to understand disease pathways, drug mechanisms, and patient variability.
- Conduct simulations to support dose selection, trial design, and exposure-response analyses.
- Collaborate cross-functionally with R&D, clinical, regulatory, and biostatistics teams.
- Author and review clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs).
- Contribute to scientific publications and conference presentations.
Other
- 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
- Good project management skills, and the ability to collaborate with other departments and manage with internal and external partners.
