Director, Oncology Clinical Pharmacology, Modeling and Simulation
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • United States
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Job Level
About the role
- Defining and executing model-based development strategies for oncology projects
- Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection
- Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis
- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
- Write or review clinical pharmacology components of regulatory documents and responses
Requirements
- A PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics)
- 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling
- verifiable proficiency in pharmacometric tools NONMEM or R
- 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards
- Expertise in applications of AI/ML in Clinical Pharmacology and Pharmacometric analyses
- Strong drive and learning agility to build knowledge on a drug-disease system
- Demonstrated aptitude for productive collaboration in a multi-discipline team
- Experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards
- Passion for quantitative clinical pharmacology
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
model-based developmentexposure-response analysissimulation-based trial designdose selectiondrug-disease modelinglongitudinal exposure-response analysismechanistic PKPDpharmacometric toolsAI/ML applications in Clinical Pharmacologyclinical data analysis
Soft Skills
strong drivelearning agilityproductive collaboration
Certifications
PhD in Quantitative Clinical PharmacologyPhD in Pharmacometrics