Director, Clinical Science (PharmD and Phase I Oncology Experience Required)
Scorpion Therapeutics is a precision oncology company founded in February 2020 by a preeminent group of scientists from Harvard University/Massachusetts General Hospital – Keith Flaherty, MD, Gaddy Getz, Ph.D. and Liron Bar-Peled, Ph.D. The company has raised $270M in Series A and Series B financings led by blue-chip investors, including Atlas Venture, Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds, and Vida Venture.
Scorpion Therapeutics’ mission is to serve oncology patients by discovering and developing best-in-class and first-in-class, small molecule cancer medicines that address large patient segments with significant unmet medical needs. To accomplish this mission, we are building a highly collaborative team focused on the pursuit of novel approaches to small molecule drug discovery. This approach relies upon dynamic collaboration between cancer biology, proteomics, informatics, structural biology and medicinal chemistry – with the ultimate goal of realizing the full potential of targeted/precision oncology.
Our Clinical Development team has an exciting new opportunity for someone to join as an Associate Director, Clinical Science/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.
- 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.
- Advanced degree (PharmD, MD, DO, PA, NP, 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
Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.