Vice President, Early Clinical Development, Radiopharmaceutical Therapies

About the role

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.

Responsibilities

• 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.
• 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.
• Collaborate with medical physicists to integrate radiation dosimetry into clinical protocols, ensuring optimized therapeutic windows and individualized patient safety.
• Define the imaging strategy to provide early evidence of target engagement, biodistribution, and tumor response.
• Act as the lead clinical expert for meetings with global health authorities (FDA/EMA).
• Support and lead interactions with the FDA’s Division of Medical Imaging and Radiation Medicine.
• Engage with BMS oncology leaders in research and early clinical development to develop combination strategies as appropriate across the BMS and RayzeBio portfolios.

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 to 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.
• 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.
• 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.

Pay

$341,360 - $413,648

Schedule

Not specified