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Executive Director Clinical Development

4 months ago

New York, United States Discover International Full time

We have have partnered with a fast growing biotech focused on Neurodegenerative Disorders. The client have a robust pipeline of 15 early stage assets.



Role

:Executive Director or Vice President Clinical Development creating clinical development plans for Neurodegenerative Diseases


.
Key Responsibiliti

  • esLead the clinical development plan and overall clinical strategy for multiple global program
  • s.Help to identify unmet medical needs in neurodegenerative disorder
  • s.Overall responsibility for clinical study design, includin
  • g:Authoring study synopses and protocol
  • s,Collaborating with biostats to develop the statistical analysis plan (SAP
  • ),Providing medical monitoring and safety oversight to ensure the safety of subjects and adherence to the protocol and good clinical procedures (GCP
  • ).Interpreting clinical data and authoring clinical study reports (CSR
  • ).Develop strong relationships with Investigators, research sites and KOLs to design clinical trials that answer important medical question
  • s.Support publication strategy of clinical data through preparation and submission of clinical findings to scientific journals and conference
  • s.Lead clinical strategy for regulatory submissions, responses to regulatory questions and presentations at regulatory meeting

s.Qualificatio

  • nsMD, Board Certification in Neurology with 8 - 10 years of clinical development or equivalent experienc
  • e.Clinical experience in Neurolo
  • gyDemonstrated leadership, organization, and excellent written and verbal communication skill
  • s.Ability to work collaboratively in a fast-paced, team-based matrix environmen
  • t.Comfortable working in a demanding, fast-paced, start-up culture with evolving processe


s.