Clinical Imaging Scientific Director (Oncology)

Regeneron Pharmaceuticals; Tarrytown (GA); Presencial; USD 205.000 - 342.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals seeks a Clinical Imaging Scientific Director for Oncology to own strategy and execution of imaging endpoints and biomarkers across early and late-phase oncology trials. You will lead multi-modality imaging measures, collaborate with cross-functional teams, and engage regulators to advance the Regeneron clinical pipeline.

The role requires a PhD with 10+ years in clinical imaging (7+ years in oncology).

Formación

• PhD with 10+ years of clinical imaging experience, 7+ years in oncology drug development.
• Excellent written and verbal communication and organizational skills.
• Experience applying standard oncology response criteria (RECIST 1.1, iRECIST, PCWG3, Lugano, IMWG) in trials.
• Proven engagement with regulatory agencies and ability to lead imaging innovations.
• Experience as study scientific director of PET imaging biomarker trials in oncology.
• Experience using PET imaging as a quantitative endpoint in oncology studies.

Responsabilidades

• Create imaging biomarker strategies and endpoints for oncology trials.
• Present clinical imaging strategies to senior management.
• Lead and coordinate multi-disciplinary stakeholders across Regeneron.
• Design and implement multi-modality imaging measures as trial endpoints.
• Collaborate with clinical teams to ensure proper imaging design and analysis plans.
• Coordinate with Imaging Operations and CROs to ensure data integrity.
• Serve as Study Scientific Director for trials involving imaging biomarkers.
• Engage with regulators on imaging endpoints and procedures.

Conocimientos

Leadership

Cross-functional collaboration

Communication

Strategic imaging development

Study leadership

Educación

PhD with 10+ yrs imaging

Herramientas

RECIST 1.1

iRECIST

PCWG3

Lugano

IMWG

Descripción del empleo

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

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.

Does this sound like you? 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 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.

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