Clinical Research Director

Main Responsibilities

• Establish or adapt clinical development plan, including discussions with clinical investigators, advisors, and regulatory authorities; plan contingencies.
• Lead, support, and oversee execution of clinical development and studies, including:
  • Author abbreviated protocols; review final protocols and amendments.
  • Review informed consent form, written subject information, and trial disclosure form.
  • Review study-specific committee charters; lead study-specific committees (with operational support).
  • Lead clinical interpretation of study results; contribute to clinical study reports and clinical summaries.
  • Provide clinical guidance to Clinical Operations, Biostatistics, and Translational Medicine.
• Contribute to regulatory and safety documentation and discussions:
  • Review/contribute clinical sections of Investigator Brochure, IND/IMPD filings, DSUR, and development risk management plans.
  • Contribute clinical sections of NDA/CTD, regulatory meeting briefing packages, PSP/PIP.
  • Participate in Advisory Committee preparation.
• Scientific data evaluation and authorship:
  • Author clinical abstracts, conference presentations, and manuscripts (as appropriate).
  • Support advisory board planning; present/discuss development strategy and clinical results (as appropriate).

Qualifications

• MD degree or equivalent.
• Hematology/Oncology fellowship or minimum 4 years Oncology Development experience.
• Pharmaceutical medicine expertise with at least 3 years industry or academic clinical research experience.
• Late-stage clinical development experience preferred.
• Demonstrated ability to work with external investigators and multifunctional teams; ability to meet regulatory/quality/compliance standards.

Benefits (as stated)

• Well-crafted rewards package; high-quality healthcare and prevention/wellness programs; at least 14 weeks' gender-neutral parental leave.