Principal Scientist, Clinical Research, Immunology

Merck Merck · Pharma · NJ

Merck is seeking a Principal Scientist, Clinical Research, Immunology to lead strategic planning and execution of clinical research activities for investigational compounds in Immunology, focusing on late-stage development. Responsibilities include evaluating pre-clinical data, developing clinical strategies, planning and managing clinical trials, analyzing findings, and contributing to regulatory filings and publications. The role requires strong scientific knowledge, collaboration with cross-functional teams, and engagement with external experts.

What you'd actually do

  1. primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.
  2. manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.
  3. Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
  4. Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategies
  5. Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication

Skills

Required

  • Allergy and Immunology
  • Clinical Development
  • Clinical Immunology
  • Clinical Investigations
  • Clinical Medicine
  • Clinical Research
  • Clinical Trial Planning
  • Clinical Trials
  • Clinical Trial Support
  • Cross-Functional Teamwork
  • Immunogenicity Assays
  • Intellectual Curiosity
  • Strategic Planning

Nice to have

  • Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases

What the JD emphasized

  • late-stage development
  • clinical development strategies
  • clinical trials