Senior Quantitative Pharmacology and Pharmacometrics Leader

4 weeks ago

Dana Point, California, United States Merck Sharp & Dohme Full time
Job DescriptionLead Quantitative Pharmacology and Pharmacometrics Expert

The Quantitative Pharmacology and Pharmacometrics Department at Merck Sharp & Dohme is seeking a highly skilled and experienced Director to support our rapidly expanding ophthalmology pipeline. This position can be located in various locations within the company.

Key Responsibilities:

  • Develop model-based strategies for quantitative analyses to inform and optimize drug discovery and development.
  • Represent the QP2 Department on ophthalmology discovery, early clinical development, and late clinical development teams.
  • Collaborate with other functional areas and external vendors to create a quantitative and model-informed regulatory framework.
  • Maintain a comprehensive understanding of global regulatory expectations and shape, present, and defend regulatory documents and submissions.
  • Mentor or supervise early career scientists to grow their skill sets.

Requirements:

  • Ph.D. or equivalent degree with at least seven years of experience, or PharmD or equivalent degree with at least nine years of experience, or 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.
  • Direct experience in regulatory interactions, proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Preferred Qualifications:

  • Ability to influence regulatory strategies and independently formulate registration packages to support global filings.
  • Experience in performing population PK/PKPD analyses using standard pharmacometrics software.
  • 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.

We are committed to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to make meaningful contributions to global medical advancement.

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