Clinical Imaging Scientific Director (Oncology)

Overview

The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of complex early through late-phase oncology imaging in clinical trials where imaging plays a key role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will champion the development of imaging endpoints and biomarkers and drive the scientific imaging aspects as well as tumor response assessment of oncology clinical studies in partnership with clinical sciences and preclinical research teams.

Responsibilities

Create fit-for-purpose imaging biomarker strategies and work closely with research, clinical imaging and the oncology therapeutic area for the development of imaging endpoints to inform and advance the Regeneron clinical pipeline.

Prepare and present clinical imaging strategies to senior management.

Manage a complex network of stakeholders across Regeneron.

Lead, design and implement multi-modality imaging measures as endpoints for oncology therapeutic clinical studies.

Collaborate closely with Regeneron clinical teams as imaging subject matter expert to ensure optimal design and execution of imaging strategy including development of protocols, imaging endpoints, imaging manuals, imaging charters, statistical analysis plans and clinical study reports.

Work closely with Clinical Imaging Operations and imaging contract research organizations to ensure the flawless conduct and data integrity of studies’ imaging components and endpoints.

Serve as Study Scientific Director for clinical trials focused on qualification and utilization of novel imaging biomarkers.

Lead the interaction with regulatory agencies for communications regarding imaging endpoints and procedures.

Lead the interaction with regulatory agencies and site ethic committees for approval of clinical imaging biomarker development studies.

Qualifications

Experience as study scientific director of PET imaging biomarker clinical trials in Oncology.

Experience applying PET imaging as a quantitative endpoint in clinical and preclinical studies in Oncology.

People management experience.

Direct experience with preclinical oncology imaging models using PET and immuno-PET imaging biomarkers.

Strong background in oncology, biology, molecular imaging, radiopharmceuticals and familiar with precision medicine approaches.

Imaging CRO oversight and implementation of quality control procedures.

To be considered for this role, you must have a PhD with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development).

Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials is required.

Successful engagement experience with regulatory agencies and the ability to champion imaging innovations and lead projects effectively.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and / or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$202,000.00 - $336,600.00

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