Executive Medical Director, Clinical Development

4 days ago


Cambridge, United States ARTO Full time

We're partnered with a Pharmaceutical company to source an Executive Medical Director, they are currently focused on advancing a large early Oncology pipeline spanning several innovative technology platforms for more than a dozen tumor types.


If you're interested in this type of mission and would enjoy working in a fast paced environment look further down for more details...


Key Responsibilities:


  • Participate in the development of product development plans and lead clinical trial strategy for given project/program
  • Serve as an internal clinical expert in translational and clinical oncology.
  • Ensures projects/programs are delivered in compliance with GCP requirements and global ethical and regulatory standards
  • Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
  • Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data
  • Ensure appropriate training, recruitment, and development requirements for matrix team resources.
  • Participate in preparation of protocols , Investigator Brochures, clinical study reports, safety reports, and the clinical sections of Annual Reports , INDs / IMPDs , NDAs / MAAs , SOPs , pediatric investigation plans , as well as abstracts and manuscripts


Experience/Knowledge:


  • Experience with Regulatory Authorities such as FDA and/or EMA
  • Cross functional team collaboration experience
  • Experience in early to late phase clinical trials (phase 1, 2 and 3)


Requirements:


  • Medical Degree (M.D) and Board Certified in Oncology (Preferred)
  • 5+ years experience in Clinical Development within the pharmaceutical industry
  • Willing to travel to Cambridge, Massachusetts on a hybrid basis


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