Senior Quantitative Pharmacologist
Regeneron
Full-time
On-site
Tarrytown, NY
Clinical Research and Development
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Role Summary
Senior Quantitative Pharmacologist responsible for executing PK, PD, and other quantitative analyses to support multiple programs, and for timely delivery of nonclinical or clinical study reports and regulatory submission documents.
Responsibilities
- In collaboration with team members, plan, design, implement and analyze results for PMx studies with modest supervision.
- Perform quantitative PK or PK/PD analyses (e.g., NCA, compartmental modeling, PopPK, translational modelling, disease modelling, E-R analyses) to deliver PMx results; develop interpretation and discussion of results with supervision.
- Collaborate with PMx Research Specialists, PMx Programming Team, Scientific Writers, and others to prepare technical reports and regulatory documents (PK/PD study reports, IND/CTA, CSR summaries, IB, etc.). Work with Scientific Writing, QC and QAA to finalize documentation for regulatory submissions.
- With mentorship from senior PMx staff, prepare materials for regulatory interactions and background packages (pre-IND, EOP2, pre-BLA); perform additional analyses as required to support regulatory interactions.
Qualifications
- Required: PhD and 3+ years of relevant experience with advanced quantitative concepts and techniques (non-compartmental analysis, compartmental modeling, translational modelling/pharmacology, exposure–response analysis, nonlinear mixed effects modeling, disease modelling/QSP).
- Required: experience with PMx statistical methods applicable to clinical trials (survival analysis, stratified/covariate analyses, missing data handling, logistic regression, Bayesian approaches).
- Familiarity with regulatory/research guidelines on drug development (e.g., ICH, GxP).
Skills
- Excellent interpersonal and written/oral communication; ability to function independently.
- Strong collaboration across cross-functional teams; ability to prepare material for regulatory interactions.
- Proficiency with PMx tools and statistical methods relevant to PK/PD analyses.
Education
- PhD required.