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Executive Director Clinical Development

3 months ago

New York, New York, United States Discover International Full time

We partnered with a rapidly expanding biotech company specializing in Neurodegenerative Disorders. They boast a strong pipeline of 15 early-stage assets.

Job Title: Executive Director/Vice President Clinical Development
  • Lead the clinical development plan and overall strategy for multiple global programs
  • Identify unmet medical needs in the neurodegenerative disorder field
  • Take charge of clinical study design, including:
  • Authoring study synopses and protocols
  • Collaborating with biostatisticians on the statistical analysis plan (SAP)
  • Providing medical monitoring and safety oversight to ensure subject safety and adherence to good clinical procedures (GCP)
  • Interpreting clinical data and creating clinical study reports (CSR)
  • Establish strong relationships with Investigators, research sites, and Key Opinion Leaders (KOLs) to design trials answering crucial medical questions
  • Support publication strategy of clinical data by preparing and submitting findings to scientific journals and conferences
  • Lead the clinical strategy for regulatory submissions, address regulatory inquiries, and participate in regulatory meetings
Qualifications:
  • MD, Board Certified in Neurology with substantial clinical development experience
  • Clinical background in Neurology
  • Demonstrated leadership, organization, and exceptional written and verbal communication skills
  • Ability to collaborate in a fast-paced, team-based environment
  • Comfortable in a demanding, evolving startup culture