Merck KGaA Darmstadt Germany - Rahway, NJ

posted 7 days ago

Full-time - Senior
Onsite - Rahway, NJ
Chemical Manufacturing

About the position

The Director (Principal Scientist) is responsible for planning and directing clinical research activities for new or marketed Oncology medicines. This role encompasses the entire cycle of clinical development, including study design, monitoring, analysis, regulatory reporting, and publication. The Director will collaborate with cross-functional teams and supervise Clinical Scientists to ensure the successful execution of clinical studies.

Responsibilities

  • Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
  • Develop clinical development strategies for investigational or marketed Oncology drugs.
  • Plan clinical trials based on clinical development strategies, including design and operational plans.
  • Monitor and manage ongoing or new clinical trials for investigational or marketed Oncology drugs.
  • Analyze and summarize clinical findings to support safety and efficacy decisions, new drug applications, and clinical study reports.
  • Participate in internal and joint research project teams relevant to new compounds and marketed compounds.
  • Supervise Clinical Scientists in executing clinical studies.
  • Collaborate with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
  • Assist Senior/Executive Director in keeping Corporate personnel informed about study progress and competitor drug developments.

Requirements

  • M.D. or M.D./Ph.D. required.
  • Experience in industry or academia is essential.
  • Demonstrated record of scientific scholarship and achievement.
  • Proven track record in clinical medicine and background in biomedical research.
  • Strong interpersonal skills and ability to function in a team environment.

Nice-to-haves

  • Board Certified or Eligible in Oncology (and/or Hematology).
  • GU Medical Oncologist or Uro-Oncologist specializing in bladder cancer.
  • Prior specific experience in clinical research and prior publication is desirable.

Benefits

  • Bonus eligibility
  • Long term incentive if applicable
  • Health care and other insurance benefits for employee and family
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Sick days
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