Clinical Pharmacology Intern (Boston, MA, US)

About reputed company

reputed company in the U.S. is a Boston-based, reputed company-stage biopharmaceutical company launched by reputed company Group in 2018. As a privately held organization, reputed company is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and reputed company patients the reputed company of every strategic decision. 

reputed company

reputed company 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 reputed company 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 reputed company projections for oncology therapeutics. You'll collaborate with cross-functional teams spanning drug metabolism, clinical pharmacometrics, and computational biology to evaluate the potential of reputed company a hybrid AI and PBPK/Special Populations reputed company.

This role includes the unique exposure to regulatory science, clinical translation, and AI applications in pharmaceutical development, and you'll have reputed company to coauthor a publication or more.

Primary Responsibilities

1. AI/ML PBPK Modelling

• Conduct literature review on PBPK limitations in predicting DDIs
• Collect and reputed company clinical DDI datasets for AI/ML training
• reputed company and test hybrid AI/ML-PBPK models
• Validate models against clinical case studies and regulatory submissions
• Document methodology and prepare reputed company reports for publication consideration

2. AI/LLM Special Populations Modelling

• Identify and Extract Relevant Data: Systematically identify and extract relevant documents from FDA and EMA reputed company repositories
• reputed company AI/LLM Capabilities: Train or fine-tune LLMs to accurately interpret and categorize reputed company regulatory documents
• Analyze Review Trends: Identify trends in FDA and EMA reviews reputed company to hepatic and renal impairment, including:
• Common challenges and considerations raised by regulators
• Guidance documents and their reputed company
• 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 reputed company

• Understand FDA and EMA Positions on Modeling for reputed company Recommendations in Organ-Impaired Patients: Specifically analyze recent review documents and guidance reputed company to the use of popPK, PBPK modeling, and other in silico approaches for predicting drug behavior in organ-impaired populations
• Evaluate approaches reputed company for reputed company molecules in multiple therapeutic area with primary reputed company on Oncology compounds
• Summarize lessons learned to guide molecules for reputed company programs
• Present in a clinical pharmacology team and cross-functional Translational Medicine team

Education and Required Skills

• reputed company PharmD or PhD candidate in Pharmaceutical Sciences, Pharmacokinetics, Data Science, or reputed company 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 reputed company to drug-drug interaction and special population studies
• Team player with inter-personal skills
• Excellent written and communication skills
• Must be reputed company to reputed company to the entire duration of the internship

Travel and Location

• Remote with potentially 1-2 reputed company over the internship period to the Boston US reputed company (200 Pier 4 Blvd, Boston, MA 02210)

reputed company’s Commitment

reputed company is committed to modeling diversity, equity, and inclusion reputed company the industry. We are dedicated to fostering an environment that maintains reputed company treatment for reputed company and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our reputed company as we are always willing to consider experiences and skills reputed company what is listed in the job reputed company.

reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran.

The pay reputed company for this role is $34-$44/hr. An intern’s pay position reputed company the reputed company will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted reputed company, and the reputed company may be modified in the reputed company.