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

Remote option only for candidates not within commutable distance (<50 miles) to primary sites.

Category
Computational Biology
Biology Lab & Research
Biology & Biotech
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), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia.
  • 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

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Founded

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