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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Associate Director - Clinical Imaging, Oncology

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time$176.1k - $287.3k /yr

About the Job

Requirements

  • A PhD and at least 7 years of clinical imaging experience, including at least 5 years in oncology drug development.
  • Experience implementing central efficacy assessments in oncology clinical trials using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano, and IMWG.
  • Successful engagement with regulatory agencies and the ability to champion imaging innovations and lead projects effectively.

Responsibilities

  • Create fit-for-purpose imaging biomarker strategies and work with research, clinical imaging, and the oncology therapeutic area to develop imaging endpoints that inform and advance the clinical pipeline.
  • Prepare and present clinical imaging strategies to senior management.
  • Manage a complex network of stakeholders across the organization.
  • Lead, design, and implement multimodality imaging measures as endpoints for oncology therapeutic clinical studies.
  • Collaborate with clinical teams as the imaging subject matter expert to optimize imaging strategy design and execution, including developing protocols, imaging manuals and charters, statistical analysis plans, and clinical study reports.
  • Work with Clinical Imaging Operations and imaging contract research organizations to ensure proper conduct and data integrity for imaging components and endpoints of studies.
  • Serve as Study Imaging Director on clinical trials focused on qualification and utilization of novel imaging biomarkers.
  • Design and implement novel PET, immuno-PET, and other novel imaging agents and biomarkers in oncology clinical trials.
  • Lead interactions with regulatory agencies regarding imaging endpoints and procedures.
  • Lead interactions with regulatory agencies and site ethics committees to obtain approval for clinical imaging biomarker development studies.

Desired Qualifications

  • At least 7 years of imaging experience in oncology drug development and clinical PET tracer development in a pharmaceutical or biotechnology setting.
  • Experience as study scientific director of PET imaging biomarker clinical trials in oncology.
  • Experience with radiopharmaceuticals and applying imaging as a quantitative endpoint in clinical and preclinical oncology studies.
  • Experience overseeing imaging contract research organizations and implementing quality control procedures.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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