Senior Director, Clinical Development - Prostate Cancer

This role provides clinical direction and high-quality scientific and clinical knowledge to lead the strategy and execution of RayzeBio's clinical development plans for molecules in early and late development. 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 will lead cross-functional study teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio's portfolio to ensure the program meets the needs of patients and RayzeBio's business.

Responsibilities

• Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
• Lead internal study teams, and partner with investigators and CROs to design and implement clinical studies
• Work closely with GPLs to ensure development and commercial optimization of Rayze Bio assets
• 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
• As needed, serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
• Oversee regulatory submissions for assets in prostate cancer indications
• Lead cross-functional study teams and supervise and mentor clinical scientists and medical directors in executing the programs for prostate cancers
• Recruit, build, and manage a team of medical directors and clinical scientists as needed based on programmatic needs
• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption
• Willing to travel approximately 30% of the time

Education and Experience

• MD, PhD, PharmD 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 preferred but not required
• 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 working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials

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 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
• 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