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.