RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Position Summary
This role will report to the CMO and hold a key leadership position within the clinical development organization and will serve as the bridge between research, discovery, and clinical development. The Vice President of Early Development will lead the clinical strategy and medical oversight for the RayzeBio portfolio of next-generation radiopharmaceutical therapies. This role is responsible for the "First-in-Human" journey, transforming preclinical discoveries into robust, data-driven clinical programs that demonstrate early safety, biological activity, and therapeutic potential. This role provides medical direction and high quality scientific and clinical knowledge to lead the strategy and execution of RayzeBio’s clinical development plans for molecules in early development. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 0/1 FIH clinical trials. This role will lead cross-functional 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. This role will engage with BMS oncology leaders in research and early clinical development to develop combination strategies as appropriate across the BMS and Rayze Bio portfolios.
Key Responsibilities
- Clinical Development Strategy: Design and execute innovative Phase 0/1 clinical trials. Define the clinical path to proof-of-concept, including the use of theranostic pairs to accelerate patient selection.
- Translational & Medical Oversight: Lead the translation of preclinical pharmacology and toxicology into First-in-Human dosing strategies. Serve as the primary medical/scientific voice for the early-stage pipeline.
- Dosimetry & PK/PD: Collaborate with medical physicists to integrate radiation dosimetry into clinical protocols, ensuring optimized therapeutic windows and individualized patient safety.
- Imaging Strategy: Define the imaging strategy to provide early evidence of target engagement, biodistribution, and tumor response.
- Regulatory Liaison: Act as the lead clinical expert for meetings with global health authorities (FDA/EMA). Draft and defend clinical sections of IND/CTA filings, with a focus on justifying dose-escalation schemes and safety monitoring. Support and lead interactions with the FDA’s Division of Medical Imaging and Radiation Medicine.
- KOL Collaboration: Establish a network of academic investigators and nuclear medicine specialists to ensure strategic alignment with changes in therapeutic landscapes and collaboration on early development programs
- Portfolio strategy: Lead asset strategies for RayzeBio products in early clinical development.
- Mentorship: Build and mentor the RayzeBio asset teams in clinical development. Serve as manager and cross-functional leader across the RayzeBio organization.
Qualifications & Experience
- Advanced Degree: MD or PhD (MD/PhD preferred) with a specialization in Oncology, Nuclear Medicine, or a related field.
- Clinical Depth: 12+ years of drug development experience, with a proven track record of designing early-phase clinical protocols for radiopharmaceutical therapies.
- Demonstrated leadership of clinical and cross-functional teams in a biotech environment.
- "First-in-Human" (FIH) Design: A track record of designing dose-escalation studies (e.g., Bayesian Optimal Interval or 3+3 designs) specifically tailored for radioactive drugs.
- Theranostic Strategy: Expertise in implementing the "image-then-treat" paradigm, specifically the clinical use of PET/CT imaging o predict therapeutic response for RPTs
- Advanced Dosimetry Knowledge: Proficiency in clinical dosimetry protocols to determine absorbed doses to organs-at-risk and tumors, ensuring patient safety and regulatory compliance.
- Radiotoxicity Management: Deep understanding of the specific safety profiles of radiopharmaceuticals, including hematological toxicities, nephrotoxicity, and other developing safety signals
- Quantitative Imaging: Ability to oversee the integration of quantitative imaging biomarkers into early-phase trials to assess target engagement and biodistribution.
- Supply Chain & Pharmacy Coordination: Functional knowledge of "just-in-time" manufacturing, managing the clinical interface with radio pharmacies, and isotope shelf-life constraints in a trial setting.
- Patient-focused: Deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics
- Collaboration and Agility: 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.
- Leadership: 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 manage multiple stakeholder engagements across development and commercial organizations
- Communication Skills: Strong written and oral communication skills, including presentation skills. Strong critical, strategic, and analytical thinking skills.
- External KOL relationship: Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.
- Compliance: 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.
Compensation Overview:
$341,360 - $413,648
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
