Support Medical Monitor or serve as clinical lead of a phase 1a/1b study and future late-stage studies, including contributing to/overseeing study start-up, enrollment, study medical monitoring, data cleaning, and CSR writing
Partner with investigators and CROs to design and implement clinical studies, respectively
Write protocols, investigator brochures, and clinical study reports, and review clinical trial documents
Conduct investigator meetings and safety review committee meetings and lead site initiation visits with clinical trial investigators
Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
Translate findings from research and non-clinical studies into clinical development opportunities
Interact with clinical investigators and thought leaders
Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines.
Requirements
PhD or Pharm D, with at least 3 years of oncology clinical development experience
Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting
Deep commitment to understanding needs and improving the lives of patients, and a passion for developing novel therapeutics
Demonstrated ability to collaborate successfully with multiple functions in a team environment, including clinical operations, regulatory, and clinical pharmacology
Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
Motivated to work in a fast-paced, high accountability, small company environment; a "can do" and collegial professional who leads through influence and interpersonal skills
Intellectually curious with the courage to challenge and seek new ways to improve work
Strong written and oral communication skills, including presentation skills
Ability to analyze and interpret data and develop written reports and presentations of those data
Solid critical, strategic, and analytical thinking skills
Travel (US and ex-US) required, to attend scientific conferences and study sites as needed.