Executive Medical Director, Clinical Development - ARTO

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