- Pioneering clinical-stage oncology company redefining the frontier of precision medicine
- Proprietary and fully integrated platform of advanced technologies across cancer biology, medicinal chemistry, and data sciences
- Broad pipeline of wholly owned, optimized compounds targeting validated oncogene targets, previously undruggable targets, and novel cancer targets
Our Clinical Development team has an exciting new opportunity for someone to join as a Director/Senior Director, Clinical Science (Early Development). This person will provide scientific and clinical expertise to develop, design, conduct, analyze, and report global clinical trials in accordance with approved clinical development plans and Health Authority (e.g., FDA/EMA, etc.) regulatory requirements.
Responsibilities:
- Contribute to oversight of trials in start-up, conduct, and close-out, for Phase I-III in close coordination with Clinical Operations
- Participate in critical site-facing activities (PSVs, SIVs, etc.); contribute to preparation of meeting materials in collaboration with the Clinical Trial Lead
- Coordinate and conduct regular data/safety/efficacy reviews and identify trends across programs in collaboration with the Global Medical Monitor
- Contribute to the cross functional trial team as the clinical sciences lead
- Participate with the study team to prepare for and execute regulatory milestones
- Contribute to the development of study documents for activities around study conduct (e.g., protocols, IBs, eCRFs, meeting abstracts, manuscripts, RECIST/IWG training materials), regulatory requirements (e.g., briefing documents), and IDMCs (e.g., charters)
- Work with statisticians/biometrics to develop the required tables/listings/figures and contribute to the interpretation of efficacy and safety data from clinical trials
- Present safety findings and study status to internal stakeholders (e.g., safety working group/senior management meetings)
- Coordinate presentations at IDMC meetings, and other meetings, such as Investigator and Safety Review Meetings
- Participate in various initiatives and duties as required by the clinical development program
