Job Description
Join NeuroGen Therapeutics, a leader in CNS drug development, as we pioneer next-generation treatments for neurological disorders. We seek a dynamic Senior Clinical Research Manager to oversee pivotal phase II/III trials for our groundbreaking Alzheimer's therapy. This role offers unparalleled impact in a collaborative, science-driven environment at our Boston headquarters.
Responsibilities
- Lead end-to-end clinical trial execution from protocol design to FDA submission
- Manage cross-functional teams including CROs, investigators, and internal stakeholders
- Oversee regulatory compliance and ensure adherence to ICH-GCP standards
- Develop innovative risk mitigation strategies for complex neurological trials
- Drive site activation and recruitment optimization for diverse patient populations
- Lead data analysis and reporting for FDA/EMA submissions
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- MS/PhD in Life Sciences or related field with 8+ years clinical research experience
- Proven track record managing phase II/III CNS/neurology trials
- ICH-GCP and FDA regulatory expertise with successful audit history
- Strong proficiency in eClinical systems (Veeva RIM, Medidata Rave)
- Exceptional leadership skills with global CRO management experience
- Published research in peer-reviewed neurological journals preferred
- Certified Clinical Research Professional (CCRP) required