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. #J-18808-Ljbffr