Senior Principal Scientist (senior Director), Clinical Research, Gi Oncology

Merck Merck · Pharma · NJ

This role focuses on planning and directing clinical research for new and marketed Oncology medicines within Merck. Responsibilities include study design, monitoring, analysis, regulatory reporting, and publication, managing the entire cycle of clinical development from pre-clinical to post-licensure. The Senior Director will lead cross-functional teams and maintain scientific knowledge in the field of oncology.

What you'd actually do

  1. Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
  2. Development of clinical development strategies for investigational or marketed Oncology drugs
  3. Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
  4. Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs
  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 publications

Skills

Required

  • Clinical Development
  • Clinical Judgment
  • Clinical Medicine
  • Clinical Reporting
  • Clinical Studies
  • Clinical Trial Development
  • Clinical Trials
  • Drug Development
  • Gastrointestinal Oncology
  • Medical Monitoring
  • Medical Research
  • Oncology
  • Oncology Trials
  • Regulatory Affairs Compliance
  • Research Methodologies

Nice to have

  • Successful completion of an ACGME-medical oncology, combined medical oncology/hematology or pediatric hematology fellowship
  • Board Certified in adult or pediatric oncology (and/or hematology)
  • A proven track record in clinical academic medicine with a focus on adult GI medical oncology, proficient in the GI oncology treatment landscape with academic publication experience

What the JD emphasized

  • M.D or M.D./Ph.D.
  • Minimum 3 years of clinical medicine experience in adult or pediatric oncology and/or hematology
  • Minimum 1 year of drug-development/pharmaceutical industry experience or biomedical research experience in academia/fellowship
  • Demonstrated record of scientific scholarship and achievement
  • Strong interpersonal and communication skills, as well as the ability to function in a large cross-functional team environment are essential.