Senior Director, Clinical Development – Prostate Cancer

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement the clinical development strategy for RayzeBio's prostate cancer assets.

• Oversee clinical development plans throughout the entire lifecycle, from IND to Phase 3 registrational studies.

• Expand and manage the prostate cancer clinical team, including recruiting medical directors and clinical scientists as necessary.

• Collaborate with research and translational medicine teams on clinical-stage assets and pipeline molecules.

• Engage in business development and due diligence activities to enhance RayzeBio’s portfolio.

• Collaborate with BMS oncology leaders to create combination strategies and support initiatives in prostate disease areas.

• Provide clinical guidance and scientific expertise for both early- and late-development molecules.

• Assist in IND preparation and liaise with regulatory authorities.

• Design and implement Phase 1 to Phase 3 clinical trials, offering medical monitoring throughout.

• Lead cross-functional study teams through the phases of study design, implementation, monitoring, analysis, and reporting.

• Engage with clinical investigators and thought leaders to formulate development plans.

• Partner with investigators and CROs to design and conduct clinical studies.

• Collaborate with GPLs to enhance the development and commercialization of RayzeBio assets.

• Contribute to the creation of protocols, investigator brochures, clinical study reports, and regulatory documents.

• Facilitate investigator meetings and lead site qualification and initiation visits.

• Implement strategic plans, develop contingency measures, provide technical and strategic insights, and achieve milestones and budgets.

• Convert research and nonclinical findings into actionable clinical development opportunities.

• Supervise Data Review and Independent Data Monitoring Committees.

• Ensure that clinical trials adhere to ethical standards and applicable pharmaceutical industry regulations.

• Maintain professional relationships with clinical trial investigators and key opinion leaders.

• Direct regulatory interactions, including briefing documents, health authority meetings, and submissions related to prostate cancer assets.

• Mentor and supervise clinical scientists and medical directors.

• Utilize AI to enhance program, portfolio, and functional performance.

⛳️ Requirements

• A degree in MD, PhD, PharmD, or an equivalent qualification is mandatory.

• A minimum of 10 years of experience in pharmaceutical, biotech, or academic settings focusing on oncology solid tumor clinical development.

• Training in an oncology subspecialty is ideally required or preferred.

• Experience with radiopharmaceuticals is preferred but not mandatory.

• Background in drug development specifically related to prostate cancer is advantageous but not essential.

• Familiarity with NDA/MAA preparation and submission processes is required.

• Experience with complex interactions with global health authorities is necessary.

• Comprehensive understanding of all aspects of early- and late-phase protocol execution, including writing, study initiation, execution, analysis, and reporting.

• Proven ability to work closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other personnel.

• Demonstrated leadership capability in clinical and cross-functional teams within a biotech environment.

• Excellent written, verbal, and presentation skills.

• Strong critical, strategic, and analytical thinking abilities.

• Proficient in clinical research as well as pharmaceutical product development and approval processes.

• Ability to operate within a highly regulated environment while adhering to RayzeBio guidelines and SOPs.

• Solid understanding of GCP and ICH guidelines is essential.

• Willingness to travel approximately 30% of the time.

🏝️ Benefits

• Additional discretionary incentive cash and stock opportunities.

• Wellbeing support services.

• Retirement and financial protection benefits.

• Comprehensive medical, dental, vision, life, and disability insurance options.

• Flexible Time Off (FTO) policy with no set accrual limit for eligible U.S.-based exempt employees.

• 11 paid company holidays each year.

• 160 hours of paid vacation annually for eligible new hires.

• 3 optional holidays available for eligible employees.

• Paid sick leave depending on eligibility.

• Up to two paid volunteer days each year, subject to eligibility.

• Flexible summer hours based on eligibility.

• Leaves of absence available for medical, personal, parental, caregiver, bereavement, or military reasons.

• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.

• Reasonable workplace accommodations/adjustments and ongoing support provided.