Senior Principal Scientist (senior Director), Clinical Research, Adc

Merck Merck · Pharma · NJ

Senior Principal Scientist (Senior Director) in Clinical Research for Oncology Asset therapeutic area at Merck. Responsibilities include planning and directing clinical research activities for new medicines, from early to late clinical development. This involves study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The role also includes evaluating pre-clinical and translational work, developing clinical development strategies, and providing expert scientific opinion.

What you'd actually do

  1. Planning and directing clinical research activities involving new medicines in the Oncology Asset therapeutic area.
  2. Manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
  3. Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
  4. Developing clinical development strategies for investigational drugs
  5. Medical oversight and overall conduct of ongoing or new clinical trials for investigational drugs, including dose optimization studies

Skills

Required

  • Antibody Drug Conjugates (ADC)
  • Clinical Development
  • Clinical Documentation
  • Clinical Medicine
  • Clinical Reporting
  • Clinical Trial Development
  • Clinical Trials
  • Drug Development
  • Ethical Standards
  • Oncology
  • Pharmaceutical Development
  • Regulatory Compliance
  • Regulatory Reporting
  • Strategic Planning
  • industry or as senior faculty in academia
  • clinical medicine experience
  • industry experience in drug development or biomedical research experience in academia
  • overseeing clinical studies and protocols
  • scientific scholarship and achievement
  • clinical medicine and background in biomedical research
  • interpersonal skills
  • team environment

Nice to have

  • Board Certified or Eligible in Oncology or related discipline
  • Prior specific experience in clinical research
  • prior publication

What the JD emphasized

  • Must have experience in industry or as senior faculty in academia
  • Minimum of 3 years clinical medicine experience
  • Minimum of 3 years of industry experience in drug development or biomedical research experience in academia
  • Demonstrated success in overseeing clinical studies and protocols
  • Demonstrated record of scientific scholarship and achievement
  • Proven track record in clinical medicine and background in biomedical research