Medical Director, Clinical Development - Neurology
EPM Scientific · Paramus, NJ · 1 mo ago
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Responsibilities
- Contribute to clinical development strategy and clinical trial planning across programs
- Support the design and execution of clinical trials, partnering closely with internal and external clinical operations teams to ensure effective delivery
- Provide medical and scientific expertise to support drug development and address key clinical and translational questions
- Serve as, or oversee, medical monitoring activities throughout clinical studies
- Contribute to pharmacovigilance efforts, including safety signal evaluation, SAE review, and ongoing safety data analysis
- Support the development of key clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, and regulatory submissions (INDs, NDAs, etc.)
- Engage with regulatory authorities as needed to support clinical development programs, submissions, and inspections
- Lead and maintain relationships with external experts, investigators, and scientific advisors to support study design and execution
Qualifications
- M.D.
- At least 2 years of clinical development experience within the pharmaceutical or biotechnology industry, ideally with Neurology Programs