Senior Principal Scientist, Pharmacometrics Leader

2 weeks ago


Helena, Montana, United States J&J Family of Companies Full time
Job Summary

We are seeking a highly skilled Senior Principal Scientist, Pharmacometrics Leader to join our team at J&J Family of Companies. As a key member of our Clinical Pharmacology & Pharmacometrics (CPP) department, you will be responsible for applying and promoting clinical pharmacology expertise to drive the development of innovative medicines.

Key Responsibilities
  • Develop and implement clinical pharmacology strategies for compound development, including interactions with regulatory agencies.
  • Lead the design of clinical pharmacology components of clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD).
  • Collaborate with cross-functional teams to develop compound-specific clinical pharmacology strategies and provide expertise on PK, PD, and translational medicine.
  • Prepare and present CP contributions to regulatory documents, including briefing books, submission packages, and responses to health authority questions.
  • Stay up-to-date with regulatory guidance, analysis methodology, and overall drug development process, and identify opportunities for scientific and technical advancement within the department.
Requirements
  • Master's or PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences.
  • 9+ years of experience in pharmaceutical, biomedical, or related field, with advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.
  • Experience with modeling tools, such as NONMEM, R, Gastroplus, Simcyp, Winnonlin, and Matlab.
  • Strong understanding of US, European, and Asian regulatory requirements and guidelines.
  • Excellent communication and presentation skills, with ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.
What We Offer

We offer a highly competitive compensation package, including a base salary range of $135,000 to $232,300, and an annual performance bonus. Additionally, we provide a comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may also be eligible to participate in our consolidated retirement plan (pension) and savings plan (401(k)).

We are an Affirmative Action and Equal Opportunity Employer, committed to diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.



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