Vice President, Early Clinical Development, Radiopharmaceutical Therapies

Vice PresidentVice PresidentFull TimeRemoteLeadTeam 10,001+Since 1887H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$341.4K - $413.6K / year

Seniority

Lead

Postgraduate Degree12 yrs expEnglishGoogle Cloud Platform

Job Description

Vice President, Early Clinical Development, Radiopharmaceutical Therapies

Bristol Myers Squibb

• 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.

Job Requirements

  • 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.

Benefits

  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays.
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day.

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