Senior Principal Scientist - Oncology Imaging

Regeneron; New York (NY); Remote; USD 170,000 - 230,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a senior leader to drive the strategy and execution of imaging in oncology trials.

You will lead multimodality imaging endpoints and biomarker development across early and late‑phase studies, collaborating with clinical and external partners. They will require expertise in RECIST and related response criteria, as well as experience managing imaging CROs and regulatory interactions.

Qualifications

• Experience implementing central efficacy assessment using tumor response criteria (RECIST 1.1, PCWG3, Lugano, IMWG).
• Ability to lead imaging as a quantitative endpoint in oncology trials.

Responsibilities

• Formulate imaging biomarker strategies to inform Regeneron clinical pipeline.
• Lead design and implementation of multimodality imaging measures as trial endpoints.
• Collaborate with clinical teams as imaging SME to design protocols, manuals and analysis plans.
• Oversee imaging data integrity and CRO collaborations across studies.
• Serve as Imaging Scientific Lead for biomarker development in trials.
• Interface with regulators and ethics committees for imaging studies.

Skills

Oncology imaging

Imaging biomarkers

Clinical trial leadership

Regulatory engagement

PET imaging

Immuno-PET

CRO oversight

Education

PhD or MD

Job description

The successful candidate will lead the strategy and execution of complex early and late phase oncology imaging in clinical trials where imaging plays a critical role. Imaging includes all modalities with a special focus on PET and CT. In this role, you will lead the development of imaging biomarkers, support the scientific imaging aspects and tumor response assessment of oncology clinical studies. You will be a member of cross-functional program teams including Regeneron clinical and preclinical colleagues as well as external academic and industry partners.

This position offers excellent opportunities to develop innovative imaging biomarkers in support of clinical development and to bring treatment options to patients.

When & where:

Locations: Willing to work from one of the following sites:

• Warren, NJ
• Cambridge, MA
• Open to Remote for the right candidate

Discover your role:

• Work closely with imaging, therapeutic area and development leads to formulate appropriate imaging biomarker strategies to inform and advance the Regeneron clinical pipeline.
• Lead, design and implement multimodality 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, imaging charters and statistical analysis plan.
• Work closely with Clinical Imaging Operations and imaging CROs to ensure the flawless conduct and data integrity of study's imaging components and endpoints.
• Serve as Imaging Scientific Lead in clinical trials focused on qualification and utilization of novel imaging biomarkers.
• Lead the interaction with regulatory agencies and site ethic committees for approval of clinical imaging biomarker development studies.
• Design and implement novel PET, immuno-PET and other novel imaging agents/biomarkers in clinical trials.
• Oversee image analysis and interpretation of results, work closely with colleagues to oversee the development of study reports and publications as appropriate.
• Design and implement innovative imaging translational strategies in collaboration with preclinical/clinical research teams and external partners.

This role requires:

• Experience in the implementation of central efficacy assessment using tumor response criteria such as RECIST 1.1, PCWG3, Lugano and IMWG in oncology clinical trials.
• Leadership experience in the application of imaging as a quantitative endpoint in clinical and preclinical studies with an oncology focus.
• A Doctorate degree in a relevant field, with 5+ years of industry and academic clinical oncology imaging experience.
• Proven excellent written/verbal communication and organization skills.
• Ability to champion imaging innovations and lead projects effectively.
• Preferred: Minimum 5+ years of imaging experience in oncology drug development and clinical PET tracer development in a pharmaceutical/biotechnology setting. Level commensurate with years of experience.
• Preferred: Experience in the application of imaging as a quantitative endpoint in clinical and preclinical studies.
• Preferred: Experience with regulatory agencies and inspections.
• Preferred: Direct experience with preclinical oncology imaging models using PET and immuno-PET imaging biomarkers.
• Preferred: Strong background in oncology, biology, molecular imaging and familiar with precision medicine approaches.
• Preferred: Imaging CRO oversight and implementation of quality control procedures.