Clinical Imaging Scientific Director (Oncology)

Regeneron Pharmaceuticals Inc.; Cambridge (MA); On-site; USD 205,000 - 342,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. seeks a Clinical Imaging Scientific Director for Oncology to own the strategy and execution of advanced oncology imaging in clinical trials, with emphasis on PET and CT, imaging endpoints, and biomarkers.

The role leads cross-functional teams, presents strategies to senior management, and ensures data integrity across Regeneron and external partners. On-site work with multi-site collaboration is expected.

Qualifications

• PhD with 10+ years of clinical imaging experience, oncology drug development preferred.
• Experience engaging with regulatory agencies and leading clinical imaging initiatives.
• Experience as study scientific director of PET imaging biomarker trials in Oncology.

Responsibilities

• Create fit-for-purpose imaging biomarker strategies for oncology trials.
• Lead multi-modality imaging measures as endpoints for studies.
• Prepare and present imaging strategies to senior management.
• Collaborate across Regeneron teams and external partners.
• Ensure data integrity and regulatory alignment of imaging components.

Skills

Imaging biomarker strategy

Multi-stakeholder leadership

Regulatory engagement

RECIST/iRECIST/PCWG3 knowledge

PET imaging expertise

Education

PhD in a relevant field

Job description

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 as well as tumor response assessment of oncology clinical studies.

The successful candidate will be an independent imaging scientific leader and a member of cross-functional program teams including Regeneron clinical and preclinical colleagues as well as external academic and industry partners. This position provides excellent opportunities to develop innovative imaging endpoints and biomarkers in support of clinical development and contribute to bringing new treatment options to patients.

When & Where: Tarrytown, NY, Cambridge, MA, or Warren, NJ four days per week.

Discover your role:

• 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 ethics committees for approval of clinical imaging biomarker development studies

This role requires:

• PhD program with a minimum of 10+ years of clinical imaging experience (minimum of 7 years within oncology drug development).
• Superior written/verbal communication and organization skills.
• Experience implementing central efficacy assessments using tumor response criteria such as RECIST 1.1, iRECIST, PCWG3, Lugano and IMWG in oncology clinical trials is needed.
• We also are looking for you to have had successful engagement experience with regulatory agencies and the ability to champion imaging innovations and lead projects effectively.
• 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.

We are committed to building a workplace with an inclusive culture.

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 necessary, we disclose salary ranges for roles in all countries in which we operate.

The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.

In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together.

For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$205,000.00 - $341,600.00