Specialist, RPT Production Planning and Scheduling

Location: Remote

Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Specialist, RPT (Radiopharmaceutical Therapies) Production Planning and Scheduling will be responsible for facilitating and managing patient dose scheduling, consistent with RayzeBio   corporate goals and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations. The role will require significant collaboration across internal and external functions to ensure on-time delivery of patient clinical materials. This role will also ensure that such operations activities    are timely, efficient, and of the highest quality.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

  • Create and maintain detailed study and site tracking for patient dosing schedules across all clinical programs
  • Manage and collaborate with internal and external functions for all aspects of the patient treatment schedule and dosing, including scheduling of study participant dosing, receipt and processing of drug product orders, liaison to the Clinical team on the status of drug product manufacturing, shipments and receipt
  • Provide support, address issues and facilitate operational continuity for the on-time delivery of patient clinical materials
  • Key liaison between the Clinical Site Operations, Supply Chain and Logistics, and Radiochemistry teams
  • Identify, mitigate, and manage closely potential risks associated with the on-time delivery of patient clinical materials and escalate accordingly to the Head of Clinical Site Operations and Head of Clinical Operations
  • Drive and implement continuous improvement in the planning and scheduling of patient clinical materials
  • Collaborate with IT Business Partners in support of modeling and scheduling simulation implementations
  • Maintain and update study-level clinical site procedures for RPT dose management
  • Performs other tasks as assigned
  • Ability to travel approximately 10% of time

Education and Experience

  • Minimum 2 years of relevant experience with clinical operations, materials management and/or supply chain
  • BA/BS degree

Skills and Qualifications

  • Independent professional who proactively communicates frequently and effectively.
  • Organized and able to work on multiple projects with tight deadlines.
  • High energy level; positive attitude; works well under stress.
  • Hands-on, action-oriented, and able to implement effectively.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision and distance vision. 

Work Environment

The noise level in the work environment is usually moderate.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Employee assistance programs (EAP) and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance and supplemental health insurance. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, and sick time off. Parental, caregiver, bereavement, and military leave. Other perks like tuition reimbursement.

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