Associate Director, Metabolic and Cardiovascular Imaging, Clinical Imaging
Responsibilities:
- Spearhead imaging biomarker strategy and implementation across cardiovascular and metabolic indications in early- and late-phase clinical trials.
- Lead design of complex imaging approaches to test efficacy and safety of Regeneron products; develop and validate novel imaging-based biomarkers.
- Collaborate with Research and Global Development colleagues to formulate imaging biomarker strategies to inform and advance the clinical pipeline.
- Provide leadership during study design strategy: guide all imaging aspects, present integrated biomarker imaging components to senior management, and author key study documents.
- Partner with Clinical Imaging Operations and Clinical Trial Management to ensure high-quality imaging data delivery, including drafting imaging manuals, supporting study start-up, and monitoring data integrity.
- Supervise imaging CROs to ensure execution, resolve image quality issues, and deliver key imaging data and milestones.
- Identify imaging assessment gaps for specific indications; propose novel biomarkers and spearhead validation with internal functions and/or external institutions.
- Support regulatory submission packages as the imaging subject matter expert.
Qualifications:
- PhD or MD/PhD.
- Minimum 10 years of clinical imaging experience in cardiovascular and/or metabolic domains.
- Extensive expertise in acquisition and analysis of imaging modalities including MRI, CT, ultrasound, and echocardiography.
- Mandatory track record implementing novel imaging biomarkers in clinical studies.
- Mandatory experience in industry-sponsored clinical trials for Associate Director.
Required skills/abilities:
- Work efficiently in a fast-paced, collaborative environment.
- Communicate effectively across clinical teams/functions and with senior management.
- Broad knowledge of imaging; understand image standardization challenges across sites and countries.
- Strong analytical and problem-solving skills.
- Ability to address complex problems with innovative methods.