Vice President, Early Clinical Development, Radiopharmaceutical Therapies

 Posted 3 hours ago
     
 $341K - $413K per year
  
10+ years experience
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AI Summary

Lead the clinical strategy and medical oversight for the radiopharmaceutical portfolio, focusing on the transition from preclinical discovery to First-in-Human trials. This includes designing Phase 0/1 trials, managing regulatory interactions with the FDA/EMA, and collaborating with medical physicists on dosimetry.

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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.

Compensation Overview:

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

  • 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 (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

  • 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.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. 

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604365 : Vice President, Early Clinical Development, Radiopharmaceutical Therapies

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