Associate Director, Pharmacometrics

Entrada Therapeutics•Boston, MA

3d•$180,000 - $236,000•Remote

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 looking for someone who is enthusiastic about modeling and the big picture of drug development. You are passionate about joining a growing organization where your knowledge and experience are highly valued. You thrive in a collaborative environment, working with others to enhance infrastructure throughout the organization. You follow up and follow through, efficiently connecting problems with solutions We are seeking a dynamic and motivated Associate Director, Pharmacometrics with deep quantitative pharmacology expertise who will report to the Head of Clinical Pharmacology and partner closely across functions within a growing organization. The ideal candidate will have a strong background in the applications of model-based drug development within the biotechnology or pharmaceutical industry. The ideal candidate is passionate about translating science into approved and accessible medicines

Requirements

Ph.D. or related discipline or Pharm.D. or M.D. with relevant experience.
5+ years’ experience with a 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.
Proficient documentation and organizational skills, as well as proven ability to be self-motivated and able to work independently.
Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.

Responsibilities

Use modeling approaches to advance clinical and translational research at Entrada Therapeutics.
Lead cross-functional teams with scientific acumen to develop and execute pharmacometrics for programs across all phases of drug development.
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.
Execute pharmacometrics analyses independently to support internal and external decision making and address key drug development questions.
Integrate pharmacometrics insights into core deliverables supporting drug development milestones and governance or decision boards.
Monitor work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards, and timelines.