Associate Director Clinical Pharmacology
Regeneron
17 days ago
On-site
Tarrytown, NY
Clinical Research and Development
Role Responsibilities:
- Provide significant Pharmacometrics (PMx) contributions for R&D programs, including complex work addressing scientific advancements and regulatory hurdles.
- Independently design, conduct, and oversee PMx analysis plans; apply standardized or advanced techniques to conduct PK, PD, and other quantitative analyses; ensure accuracy.
- Serve as PMx Program Representative on program teams; communicate complex PMx results clearly and influence development teams.
- Author PMx contributions to regulatory documentation (pre-IND, EOP2, pre-BLA) and perform additional analyses to support regulatory interactions.
- Draft and review documentation for accuracy, clarity, and messaging for PMx management review.
- Collaborate with development/Research teams on PMx elements of program strategy and study design/results; present at management forums (RPR, DPR, PRC).
- Contribute to accurate tables/figures for senior management slides and help develop PMx program strategies.
- Provide leadership support to study teams on PMx deliverables/objectives and independently lead projects.
- Represent PMx at routine pre-IND, Type C, pre-BLA, and other Health Authority meetings.
Qualifications & Required Skills:
- PhD (Biology, Pharmacology, Engineering, or Pharmacy/Pharm.D., or MD) and at least 6 years of relevant Clinical Pharmacology experience.
- Expertise in PMx concepts/techniques: advanced PK/PD, non-compartmental analysis, compartmental modeling, translational modeling, exposure-response analysis, NLME, logistic regression, survival analysis, Bayesian approaches, disease modeling/QSP.
- Knowledge of innovative clinical trial PMx methodologies (e.g., survival analysis, stratified/covariate analyses, missing data strategies).
- Regulatory experience (e.g., regulatory briefing books, CTD summaries, HA meeting contributions/negotiations).
- Ability to formulate PMx objectives/design/analyses for complex clinical projects.
- Proficient with MS-Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN.
- Provide significant Pharmacometrics (PMx) contributions for R&D programs, including complex work addressing scientific advancements and regulatory hurdles.
- Independently design, conduct, and oversee PMx analysis plans; apply standardized or advanced techniques to conduct PK, PD, and other quantitative analyses; ensure accuracy.
- Serve as PMx Program Representative on program teams; communicate complex PMx results clearly and influence development teams.
- Author PMx contributions to regulatory documentation (pre-IND, EOP2, pre-BLA) and perform additional analyses to support regulatory interactions.
- Draft and review documentation for accuracy, clarity, and messaging for PMx management review.
- Collaborate with development/Research teams on PMx elements of program strategy and study design/results; present at management forums (RPR, DPR, PRC).
- Contribute to accurate tables/figures for senior management slides and help develop PMx program strategies.
- Provide leadership support to study teams on PMx deliverables/objectives and independently lead projects.
- Represent PMx at routine pre-IND, Type C, pre-BLA, and other Health Authority meetings.
Qualifications & Required Skills:
- PhD (Biology, Pharmacology, Engineering, or Pharmacy/Pharm.D., or MD) and at least 6 years of relevant Clinical Pharmacology experience.
- Expertise in PMx concepts/techniques: advanced PK/PD, non-compartmental analysis, compartmental modeling, translational modeling, exposure-response analysis, NLME, logistic regression, survival analysis, Bayesian approaches, disease modeling/QSP.
- Knowledge of innovative clinical trial PMx methodologies (e.g., survival analysis, stratified/covariate analyses, missing data strategies).
- Regulatory experience (e.g., regulatory briefing books, CTD summaries, HA meeting contributions/negotiations).
- Ability to formulate PMx objectives/design/analyses for complex clinical projects.
- Proficient with MS-Excel, R, R-Studio, Phoenix WinNonlin, NLME, NonMem, STAN.