ARTO | Executive Medical Director, Clinical Development | cambridge, ma
2 months ago
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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