Job Summary

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.

Key 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.

Professional Experience/Qualifications

• Advanced degree (PharmD, MD, DO, PA, NP, PhD, etc.) in science is required, and 3 years of experience in clinical research and/or drug development within the pharmaceutical industry. 
• Prior drug development experience in oncology is preferred 
• Experience using Medidata EDC and data visualization programs (e.g., R-Shiny, SAS, SpotFire, Tableu, Excel Pivot Tables, etc.) is preferred
• Experience in developing relationships with key investigators and KOLs
• Knowledge of GCP/ICH, study design, statistics, and basic clinical operations required
• Experience writing, editing, and reviewing protocols, informed consent templates, study manuals, conference presentations, and journal publications
• Team oriented, goal-driven, organized, and highly collaborative
• Excellent written and oral communication skills
• Ability to adapt in a fast-paced, agile team environment