Senior Principal Scientist, Clinical Research, Immunology - Ophthalmology

Merck Merck · Pharma · NJ

Senior Principal Scientist role at Merck focused on late-stage clinical research in Immunology, specifically Ophthalmology. Responsibilities include strategic planning, study design, execution, analysis, and regulatory filing for investigational compounds. Requires an MD/DO/PhD and significant experience in clinical trial design and drug development within Immunology.

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

  • M.D., D.O., M.D./Ph.D, or D.O./PhD.
  • Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology
  • Minimum of 3 years of clinical medicine experience
  • Minimum of 5 years of industry experience in drug development
  • Demonstrated record of scientific scholarship and achievement
  • Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.
  • Clinical Development
  • Clinical Documentation
  • Clinical Immunology
  • Clinical Judgment
  • Clinical Medicine
  • Clinical Research Management
  • Clinical Sciences
  • Clinical Studies
  • Clinical Trial Development
  • Data Analysis
  • Drug Development
  • Hiring
  • Ophthalmology
  • Rare Diseases
  • Scientific Consulting
  • Strategic Planning

What the JD emphasized

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