Full-Time

Director – Quantitative Pharmacology and Pharmacometrics

Confirmed live in the last 24 hours

MSD

MSD

Compensation Overview

$181.6k - $285.8kAnnually

+ Bonus + Long Term Incentive

Senior, Expert

H1B Sponsorship Available

Boston, MA, USA + 3 more

More locations: San Francisco, CA, USA | North Wales, PA, USA | Linden, NJ, USA

Hybrid position; can be located in West Point, PA, Rahway, NJ, San Francisco, or Boston.

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • a Ph.D. or equivalent degree with at least seven years of experience OR a PharmD or equivalent degree with at least nine years of experience OR an MS or equivalent degree with at least 11 years of experience
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, or a related field
  • An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry
  • Direct experience in regulatory interactions
  • Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
  • Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists
  • Knowledge in modeling of complex therapeutics
  • Flexibility to react rapidly to changing situations/environment
  • Knowledge in ophthalmology and/or cardiometabolic clinical drug development programs
  • Knowledge in modeling of complex ophthalmology therapeutics
Responsibilities
  • Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc.) for quantitative analyses, within and across development programs and/or departments, to inform and optimize drug discovery and all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions
  • Represent QP2 on ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive streamlined development of programs within our growing ophthalmology portfolio
  • Collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams
  • Collaborate with other functional areas, as well as with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data
  • Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions
  • Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities
  • Mentor or supervise early career scientists to grow their skill sets to perform project related duties
Desired Qualifications
  • Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings
  • Experience in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix, etc.)
  • Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
  • Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics
  • Experience with modeling programing language(s) (e.g. R, NONMEM, R, Phoenix, or other similar packages)

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

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