Director, Precision Medicine, Companion Diagnostics - Regeneron Pharmaceuticals : Job Details

We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy, working closely with the Senior Director, Precision Medicine CDx and key cross-functional collaborators to deliver innovative diagnostics solutions in support of Regeneron programs. The primary role will be to guide strategy for patient selection/stratification, passionate about immunohistochemistry (IHC), and lead implementation and execution of CDx assays—from study conduct and sample management to launch—in collaboration with partners/IVD sponsors and central testing laboratories to support early and late-stage oncology programs.

• Define innovative diagnostic strategies and propose projects from idea to implementation, considering all relevant inputs
• Develop strong relationships with IVD partners and testing laboratories
• Oversee operational aspects of CDx clinical trial implementation, manage timelines, and communicate effectively externally and internally
• Support regulatory teams with knowledge of regulatory requirements (including IVDR), from study setup to PMA filing, and understand Performance Study requirements to make strategic decisions in coordination with IVD regulatory counterparts
• Be recognized as a subject matter expert in oncology, effectively communicating with clinical study teams on program direction
• Define and drive CDx strategy, gaining alignment across partners including senior management within Regeneron
• Lead execution and implementation of Regeneron CDx strategy collaboratively with key partners
• Evaluate and select technologies and vendors supporting diagnostic and program deliverables
• Provide testing site implementation and oversight for CDx programs, from contracting to sample logistics and data delivery

• You possess strong leadership qualities, proactively identify problems, determine resolutions, set priorities, and manage projects cross-functionally with excellent communication and collaboration skills
• You demonstrate high emotional intelligence, work collaboratively with colleagues, vendors, and internally to ensure program success
• You lead teams in representing Regeneron and collaborating with external companies to develop and implement Precision Medicine CDx strategies

To qualify, you must have a Ph.D. and/or M.D. with a minimum of 10 years postdoctoral experience in a matrix environment, preferably in pharmaceutical, biotech, academic, or governmental cross-disciplinary teams. Extensive experience in diagnostic development with success in drug development is required. A strong understanding of technical, regulatory, clinical, and strategic aspects of diagnostic delivery is essential, with demonstrated deep knowledge in science and technology and experience in delivering diagnostics. You should also contribute to and review regulatory documents related to Precision Medicine, including product labeling, and participate in internal and external meetings.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We offer an inclusive, diverse culture with comprehensive benefits, which may include 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. All qualified applicants will receive consideration without regard to race, color, religion, sex, nationality, ethnicity, civil status, age, citizenship, sexual orientation, disability, genetic information, familial status, marital status, gender identity, gender reassignment, military or veteran status, or other protected characteristics. Reasonable accommodations are provided for known disabilities or chronic illnesses unless undue hardship occurs.

For U.S.-based roles, salary ranges are in accordance with U.S. law. For roles in Japan and Canada, salary ranges follow local laws and currencies. If outside the U.S., Japan, or Canada, please consult your recruiter regarding salaries and benefits.

Please note that background checks will be part of the recruitment process, conducted in accordance with local laws, to verify information such as identity, work rights, and educational qualifications.

Salary Range (annual): $198,000.00 - $330,000.00