· MD or equivalent ideally with sub-specialty training in oncology and at least 10 years of pharmaceutical/biotech/academic experience in oncology solid tumor clinical development is required (radiopharmaceutical experience is preferred but not required).
· Drug development experience in prostate cancer is required.
Skills and Qualifications
· Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics
· 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.
· 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.
· Demonstrated ability to collaborate successfully with multiple functions in a team environment
· Demonstrated leadership of clinical and cross-functional teams in a biotech environment
· Demonstrated ability to manage multiple stakeholder engagements across development and commercial organizations
· Intellectually curious with courage to challenge and seek new ways to improve work.
· Strong written and oral communication skills, including presentation skills.
· Strong critical, strategic, and analytical thinking skills.
· Experience in NDA/MAA preparation and submission and in complex health authority interactions globally.
· Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis and reporting.
· Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.
· Skilled in clinical research and understand the process of pharmaceutical product development and approval.
· Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
· Solid understanding of GCP and ICH guidelines.