Senior Medical Director, Clinical Development - Neurology, Epilepsy (New Jersey Based)
We're partnered with a Biotech to source a Senior Medical Director focused on developing new therapies for CNS, on a mission to change the lives of people with Epilepsy, Alzheimer's and ADHD.
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
- 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
- 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 late phase trials (phase 2,3 and 4)
Requirements:
- Medical Degree (M.D) and Board Certified in Neurology or Epileptology
- 3+ years experience in Clinical Development within the pharmaceutical industry
- Willing to travel to New Jersey on a hybrid basis
