Clinical Pharmacology Intern
About The Position
Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. Role Summary Servier is searching for a dynamic Clinical Pharmacology Intern to join our growing Clinical Pharmacology team in US. The intern will be responsible (1) to advance our AI/ML-driven approach to predicting drug-drug interactions (DDIs) in early drug development, and (2) to analyse and understand FDA and EMA review trends concerning special populations with organ impairment (hepatic and renal impairment) in drug development, leveraging Large Language Models (LLMs) and Artificial Intelligence (AI). You will contribute to an innovative research initiative that evaluates the integration of machine learning with physiologically based pharmacokinetic (PBPK) modelling and special populations with organ impairment to improve clinical dose projections for oncology therapeutics. You'll collaborate with cross-functional teams spanning drug metabolism, clinical pharmacometrics, and computational biology to evaluate the potential of develop a hybrid AI and PBPK/Special Populations framework. This role includes the unique exposure to regulatory science, clinical translation, and AI applications in pharmaceutical development, and you'll have the opportunity to coauthor a publication or more.
Requirements
- Current PharmD or PhD candidate in Pharmaceutical Sciences, Pharmacokinetics, Data Science, or related field
- Scientific knowledge of PBPK modelling concepts and AI/LLM/ML driven approaches to data analysis
- Experience with machine learning frameworks (Python, R, HuggingFace)
- Familiarity with clinical pharmacology and drug development, specifically related to drug-drug interaction and special population studies
- Team player with inter-personal skills
- Excellent written and communication skills
- Must be able to commit to the entire duration of the internship
Responsibilities
- Conduct literature review on PBPK limitations in predicting DDIs
- Collect and curate clinical DDI datasets for AI/ML training
- Develop and test hybrid AI/ML-PBPK models
- Validate models against clinical case studies and regulatory submissions
- Document methodology and prepare summary reports for publication consideration
- Identify and Extract Relevant Data: Systematically identify and extract relevant documents from FDA and EMA public repositories
- Develop AI/LLM Capabilities: Train or fine-tune LLMs to accurately interpret and categorize complex regulatory documents
- Analyze Review Trends:
- Identify trends in FDA and EMA reviews related to hepatic and renal impairment, including:
- Common challenges and considerations raised by regulators
- Guidance documents and their impact
- Specific requirements for special population studies, e.g. oncology trials vs. other indications
- Differences in review approaches between FDA and EMA
- Emerging themes or areas of focus
- Understand FDA and EMA Positions on Modeling for Dose Recommendations in Organ-Impaired Patients: Specifically analyze recent review documents and guidance related to the use of popPK, PBPK modeling, and other in silico approaches for predicting drug behavior in organ-impaired populations
- Evaluate approaches applied for Servier molecules in multiple therapeutic area with primary focus on Oncology compounds
- Summarize lessons learned to guide molecules for future programs
- Present in a clinical pharmacology team and cross-functional Translational Medicine team
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What This Job Offers
Career Level
Intern
Education Level
Ph.D. or professional degree
