Senior Scientist/Principal Scientist, Quantitative Pharmacology (Contractor)

Legend Biotech is seeking Senior Scientist/Principal Scientist, Quantitative Pharmacology (Contractor) as part of the Research & Early Development team based in Somerset, NJ. 

Role Overview

The position seeks a highly motivated and experienced quantitative pharmacologist to lead modeling and simulation efforts in support of gene and cell therapy products, with a focus on QSP and popPK modeling (Prior cell and gene therapy experience preferred).

Contract Duration: 12 Months

Key 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.  

Requirements 

• R&D, Preclinical development, Clinical, CMC and regulatory 


• 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 (Job titles will be decided per applicant’s working experience)


• 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


• 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.


• Good project management skills, and the ability to collaborate with other departments and manage with internal and external partners.


• Proven track record of scientific contributions through publications or presentations.


• Good personality, honest and trustworthy.


• Physically and mentally healthy, love life.

#Li-JR1

#Li-Contractor

#Li-Hybrid