Senior Clinical development Director

4 weeks ago


Boston, United States DNA Life Sciences LTD Full time

Senior Director Haematology/Rare Disease

As the Senior Director of Clinical Development for the rare haematological disease portfolio, you will lead ground-breaking clinical initiatives, overseeing Clinical development and global regulatory filing.


Responsibility:

  • Lead global regulatory engagement for multiple programs, preparing regulatory documents and submissions, collaborating with clinical development and other teams.
  • Offer clinical and strategic guidance for various study-related documents, including study reports, regulatory filings, protocols, and investigator brochures, working closely with cross-functional teams.
  • Provide clinical leadership for ongoing programs in rare bleeding disorders, contributing to pipeline development strategy and external partnerships.
  • Communicate program activities to senior leadership and represent the company to external stakeholders, including investigators and advocacy groups.
  • Support ongoing clinical trials by ensuring efficient study execution, data analysis, and serving as a backup Medical Monitor when necessary.


What You'll Bring:

  • MD, MD/PhD, DO, or equivalent
  • Minimum 4 years of industry experience in clinical development
  • Global clinical development and regulatory interaction experience
  • BLA/MAA filing experience preferred
  • Background in bleeding disorders preferred
  • Strong collaborative and problem-solving skills
  • Excellent communication abilities


Please reach out to shaun@dnalifesciecnes.co.uk



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