Senior/Executive Director, Program Leadership and Regulatory Operations

90 Days Old

Senior/Executive Director, Program Leadership and Regulatory Operations 2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. About Radionetics Radionetics Oncology, Inc. is a clinical stage company focused on the discovery and development of novel radiopharmaceuticals for oncology indications. Supported by notable investors and in strategic partnership with Eli Lilly, Radionetics is advancing a pipeline of first-in-class radioligands targeting G protein coupled receptors for cancers including breast and lung cancer. For more information, visit https://radionetics.com . Position Summary The Senior/Executive Director, Program Leadership and Regulatory Operations, leads strategic program management company-wide, reporting to the SVP of Regulatory Affairs, Clinical Pharmacology & Nonclinical Development. Responsibilities include coordinating pipeline activities, managing transitions from discovery to preclinical and early clinical development, and ensuring alignment with regulatory and company objectives. The role requires extensive knowledge of regulated drug development in oncology, leadership skills, operational excellence, and collaboration across multidisciplinary teams. Essential Job Functions and Duties Lead development project teams across all stages, from IND enabling nonclinical programs to clinical development. Develop and oversee project plans for compounds transitioning from discovery to nonclinical and clinical development. Coordinate and implement project plans across research, nonclinical, CMC, and clinical teams for optimal execution. Create transparent processes and criteria for development milestones and decision points. Define schedules, milestones, risks, and mitigation strategies with cross-functional teams. Conduct project reviews with leadership to optimize execution. Manage inter-dependencies and update deliverables for stakeholders. Support portfolio management and decision-making using dashboards and metrics. Lead regulatory operations including document preparation, submission, and communication with the FDA, managing templates, document flow, and internal/external document sharing platforms. Ensure budgets and contracts for regulatory and development functions are tracked and managed. Follow up with CROs on nonclinical and clinical activities. Perform additional program leadership and coordination as needed. Minimum Qualifications Advanced degree (PhD, MD, PharmD) with at least 12 years of experience in pharmaceutical R&D, specifically in oncology. Understanding or willingness to learn about radiopharmaceutical development and regulatory requirements. Proven program management and leadership skills, with success in IND submissions and R&D program advancement. Strong strategic and operational thinking abilities. Excellent communication, organizational, and interpersonal skills. Ability to motivate, influence, negotiate, and work collaboratively in a matrix organization. Experience managing project budgets; PMP certification is a plus. Other Details Location: San Diego, CA; partial remote work possible. Compensation: $250,000 - $295,000 plus benefits including bonus, equity, insurance, 401(k), PTO, and holidays. Radionetics is an equal opportunity employer and retains the right to modify job duties and requirements. We do not accept unsolicited agency referrals without prior written approval.
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Location:
San Diego, CA, United States
Salary:
$200,000 - $250,000
Category:
Management & Operations