The Clinical Imaging Scientific Director for Oncology will own the strategy and execution of sophisticated early and 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 and tumor response assessment of oncology clinical studies. This position provides excellent opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and to contribute to bringing new treatment options to patients.As a Director in Clinical Imaging, a typical day may include the following:
Create fit-for-purpose imaging biomarker strategies and work closely with research and clinical imaging, 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 and site ethic committees for approval of clinical imaging biomarker development studies
This role may be for you if:
You thrive in a matrixed environment
You are innovative and passionate about science and helping patients
To be considered for this opportunity, you are expected to have completed a PhD or MD/PhD program with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development). Superior oral and written communication skills. Experience with radiopharmaceuticals and clinical PET tracer development in oncology is required. Experience as study scientific director of PET imaging biomarker clinical trials in Oncology is preferred. We are seeking experience applying PET imaging as a quantitative endpoint in clinical and preclinical studies in Oncology. We need experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials. We need direct experience with preclinical oncology imaging models using PET and immuno-PET imaging biomarkers. Imaging CRO oversight and implementation of quality control procedures. We also are looking for you to have had successful engagement experience with regulatory agencies. Strong background in oncology, biology, molecular imaging and familiar with precision medicine approaches.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)$198,000.00 - $330,000.00