Clinical Research Director

Main Responsibilities

• Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
• Led, supports and oversees the execution of clinical development and studies activities, including but not limiting to:
• Authors abbreviated protocol.
• Reviews the final protocol and protocol amendments.
• Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
• Reviews the study specific committee charters.
• Leads study specific committees with operational support.
• Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine.
• Participates and contributes to regulatory and safety documents and discussions.
• Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans.
• Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIPP.
• Participates in Advisory Committee preparation.
• Scientific data evaluation and authorship.
• Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate.
• Supports the planning of advisory board meeting.
• Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate.

  About You

  • MD degree or equivalent.
  • Minimum 3 years industry or academic clinical development experience.
  • Hematology/Oncology experience preferred.
  • Demonstrated ability to work with a multifunctional team to achieve project milestones.
  • Understanding of and willingness to meet applicable regulatory, quality and compliance standards.