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Job Details

Senior/Executive Director, Program Leadership and Regulatory Operations

  2025-06-04     ZipRecruiter     San Diego,CA  
Description:

Job Description

About Radionetics

Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel

radiopharmaceuticals

for the treatment of a wide range of oncology indications. Supported by Frazier Life Sciences, 5AM Ventures, DCVC Bio, Crinetics Pharmaceuticals, and GordonMD Global Investments, and in strategic partnership with Eli Lilly, Radionetics is advancing a pipeline of first-in-class small molecule radioligands targeting G protein coupled receptors for cancers such as breast and lung cancer. For more information, visit

Position Summary

The Senior or Executive Director, Program Leadership and Regulatory Operations, is a key individual contributor responsible for strategic program management across the company. Reporting to the SVP of Regulatory Affairs, Clinical Pharmacology & Nonclinical Development, this role involves coordinating pipeline activities, managing transitions from discovery to preclinical and early clinical development, and ensuring alignment with regulatory requirements for oncology radiopharmaceuticals.

Essential Job Functions and Duties

  1. Lead development project teams across all stages, from IND-enabling nonclinical studies to clinical development.
  2. Develop and execute project plans for compounds transitioning through development phases.
  3. Oversee integration of project plans across functional areas to ensure optimal execution.
  4. Create and implement transparent processes for decision-making and planning.
  5. Define schedules, milestones, risks, and mitigation strategies with project teams.
  6. Conduct periodic reviews with leadership to optimize program execution.
  7. Manage stakeholder dependencies and update deliverables accordingly.
  8. Support portfolio management and decision-making using dashboards and metrics.
  9. Balance risk and creativity to meet or exceed timelines.
  10. Lead regulatory operations, including document preparation, stakeholder communication, and FDA interactions.
  11. Manage regulatory document flow, internal and external communications, and compliance.
  12. Oversee contracts, budgets, and CRO activities related to regulatory and nonclinical development.
  13. Perform additional leadership and coordination duties as needed.

Minimum Qualifications

  • Advanced degree (PhD, MD, PharmD) with =12 years in pharmaceutical R&D, especially in oncology.
  • Understanding of radiopharmaceutical development and regulatory processes.
  • Proven program management and leadership skills, including IND submissions.
  • Strong strategic, operational, and communication skills.
  • Experience with budgets and project management tools; PMP preferred.

Work Environment & Compensation

Position based in San Diego, CA, with remote work options. Compensation ranges from $250,000 to $295,000, including benefits, bonus, and equity. Radionetics is an equal opportunity employer committed to diversity and inclusion.

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