Overview RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. The Senior Medical Director Clinical Development (GU Cancer/Prostate Renal) has responsibility for the clinical development of targeted radiopharmaceuticals for treatment of solid tumors, with a focus on GU cancers. This role provides medical direction and high quality scientific and clinical knowledge to lead the strategy and execution of RayzeBios clinical development plans in GU cancers. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring. This role works collaboratively with cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBios portfolio to ensure the program meets the needs of patients and RayzeBios business. This role can be based onsite in either San Diego, CA or Lawrenceville, NJ. Responsibilities Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents Conduct investigator meetings and lead site qualification and 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 nonclinical studies into clinical development opportunities Oversee Data Review and Independent Data Monitoring Committees Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines Establish and maintain positive relationships with clinical trial investigators and thought leaders Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings Supervise and mentor clinical scientists and medical directors Willing to travel approximately 30% of the time Education and Experience MD or equivalent with sub-specialty training in oncology and at least 8 years of pharmaceutical/biotech in oncology solid tumor clinical development or equivalent academic experience. Radiopharmaceutical experience is preferred but not required. Drug development experience in GU cancer 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. Intellectually curious with 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. Strong critical, strategic, and analytical thinking skills. 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 (SOPs). Solid understanding of GCP and ICH guidelines. Physical demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment The noise level in the work environment is usually moderate. The starting compensation for this job in San Diego, CA is from $331,359 to $401,500 and in Lawrenceville, NJ is from $306,814 to $371,800 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers page text. Benefits Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include medical, pharmacy, dental and vision care, wellbeing programs, 401(k), disability and life insurance, travel protection, paid holidays, vacation, volunteer days, sick time, parental and caregiver leave, and other perks such as tuition reimbursement and a recognition program. #RayzeBio #LI-Onsite If you come across a role that intrigues you but doesnt perfectly line up with your resume, apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: San Diego - RayzeBio - CA: $331,359 - $401,529. The starting compensation range is listed above for a full-time employee basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience. For more on benefits, please visit careers page text. #J-18808-Ljbffr