Associate Director, Clinical Imaging (Oncology)
Regeneron Pharmaceuticals · Boston, MA, US
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About the Role
Lead the strategy and execution of complex early and late phase oncology imaging in clinical trials where imaging plays a key role. Champion the development of imaging endpoints/biomarkers and drive the scientific imaging aspects as well as tumor response assessment of oncology clinical studies.
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 manuals and 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 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/biomarkers in oncology clinical trials.
- Lead the interaction with regulatory agencies for communications regarding imaging endpoints and procedures.
- Lead the interaction with regulatory agencies and site ethics committees for approval of clinical imaging biomarker development studies.
Requirements
- PhD with a minimum of 7+ years of clinical imaging experience (minimum of 5 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.
- 7+ years of imaging experience in oncology drug development and clinical PET tracer development in a pharmaceutical/biotechnology setting preferred.
- Experience as study scientific director of PET imaging biomarker clinical trials in Oncology preferred.
- Experience with radiopharmaceuticals and applying imaging as a quantitative endpoint in clinical and preclinical studies in Oncology preferred.
- Imaging CRO oversight and implementation of quality control procedures preferred.
Skills
- PET
- CT
- RECIST 1.1
- iRECIST
- PCWG3
- Lugano
- IMWG
- PET imaging biomarker
- radiopharmaceuticals
- quantitative endpoint
Location
- Tarrytown, NY
- Remote
Work Type
- On-site (4 days per week)
- Remote
Experience Level
- Associate Director
- 7+ years clinical imaging experience
- 5+ years oncology drug development experience
- 7+ years imaging experience in oncology drug development preferred
- 7+ years clinical PET tracer development experience preferred
Education Level
- PhD
Salary/Compensations
- $176,100.00 - $287,300.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Equal Opportunity
- 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.