What are the responsibilities and job description for the Clinical Pharmacometrician position at Gan & Lee Pharmaceuticals?
Job Description:
The Clinical Pharmacometrician will oversee and contribute to drug pharmacodynamics (PD), pharmacokinetics (PK), and drug-drug interactions through quantitative analysis to support drug development strategies. This role involves managing CROs for modeling activities, performing modeling and simulation to support developmental needs, and integrating pharmacometrics results into development plans.
Key Responsibilities:
The Clinical Pharmacometrician will oversee and contribute to drug pharmacodynamics (PD), pharmacokinetics (PK), and drug-drug interactions through quantitative analysis to support drug development strategies. This role involves managing CROs for modeling activities, performing modeling and simulation to support developmental needs, and integrating pharmacometrics results into development plans.
Key Responsibilities:
- Oversee and manage all pharmacometric aspects of the projects.
- Serve as the primary point of contact with CROs to ensure quality, compliance,a nd adherence to timelines for all deliverables.
- Independently perform simple pharmacometric analyses and simulations to address immediate project needs.
- Provide quantitative analysis for pharmacodynamics and pharmacokinetics to support clinical development. Develop, validate, and apply drug modeling tools to support preclinical and clinical decision-making.
- Collaborate with crossfunctional teams to integrate pharmacometric results into decision-making throughout the drug development process.
- Liaise with quantitative pharmacology suppliers, implement service requirements according to project development plans, review PopPK and ER analysis plans and reports, discuss PopPK and ER analysis results, and support drug application and clinical development.
- PhD in pharmacokinetics, biostatistics, mathematics, or related fields with strong quantitative focus.
- At least 5 years of experience in quantitative pharmacology with expertise in modeling design and data analysis.
- Proficiency in tools such as NONMEM, R, or Monolix; ability to independently perform simple analyses and critically assess CRO modeling outcomes.
- Strong understanding of regulatory guidelines and expectations for pharmacometric analyses in drug development.
- Excellent communication skills and the ability to work effectively with cross-disciplinary teams.
