Pharmacometrics Consultant

Entrada TherapeuticsBoston, MA
11hRemote

About The Position

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families. We are seeking a dynamic Pharmacometrics Consultant who will bring extensive expertise in quantitative pharmacology to our clinical stage programs. The ideal candidate will have a strong background in the applications of model-based drug development within the biotechnology or pharmaceutical industry and be passionate about translating science into approved and accessible medicines. You will report directly to the Head of Clinical Pharmacology and partner closely with various functions of our growing organization.

Requirements

  • Ph.D. in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or related discipline or Pharm.D. or M.D. with relevant experience.
  • 7+ years’ experience with background in the application of mathematical, pharmacokinetics, and statistical methods within pharma/biotech industries or drug development.
  • Experience using Phoenix WinNonlin, R, NONMEM, MATLAB, or other pharmacokinetic and modeling software.
  • Strong mathematical model development and analytical skills.

Responsibilities

  • Use modeling approaches to advance clinical and translational research at Entrada Therapeutics.
  • Support the development of diverse modeling strategies and execution, in collaboration with the Head of Clinical Pharmacology, to bring value to the Entrada portfolio.
  • Work collaboratively with functional partners, including Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory to deliver on both project team and corporate objectives.
  • Author regulatory documents including analysis plans, study reports, population PK reports, exposure-response analyses reports and other similar documents.
  • Monitor work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards, and timelines.

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What This Job Offers

Job Type

Part-time

Career Level

Mid Level

Education Level

Ph.D. or professional degree

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