Senior Principal Scientist, Clinical Research, Immunology

Merck Merck · Pharma · NJ

Merck is seeking a Senior Principal Scientist, Clinical Research in Immunology to lead late-stage clinical development for investigational compounds. This role involves strategic planning, study design, execution, analysis, regulatory filing, and publication, with a focus on Rheumatology, Gastroenterology, Dermatology, and pulmonary disease. The position requires an M.D., D.O., or equivalent degree, significant industry experience in drug development, and a strong track record in clinical trial design and execution 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./PhD, or D.O./PhD.
  • Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology (Rheumatology, Gastroenterology or Dermatology)
  • 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 Medicine
  • Clinical Research Management
  • Clinical Studies
  • Clinical Trial Development
  • Clinical Trials
  • Dermatology
  • Drug Development
  • Gastroenterology
  • Inflammatory Bowel Diseases
  • Pharmaceutical Industry
  • Regulatory Compliance
  • Rheumatology

What the JD emphasized

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