Director, Precision Medicine, Companion Diagnostics

We are seeking a Director to join our Precision Medicine team. The Director, Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely with 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, sample management testing to launch) in collaboration with partners / IVD Sponsors and central testing laboratories to support early and late-stage programs within our oncology pipeline.

Make your application after reading the following skill and qualification requirements for this position.

As a Director, a typical day may include the following :

• Define innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs.
• Develop strong relationships partnerships with IVD partners and testing laboratories.
• Oversee operational aspects of CDx clinical trial implementation, manage timelines and communicate effectively both externally and internally.
• Have relevant knowledge of regulatory requirements (including IVDR) and support regulatory teams surrounding CDx (from study set up to PMA filing).

Have a solid understanding of Performance Study requirements and make strategic decisions and drive delivery in coordination with IVD regulatory counterparts.

• Be viewed as a subject matter expert in oncology and able to effectively communicate with clinical study teams on program direction.
• Able to define and drive CDx strategy and effectively gain alignment across relevant partners (including senior management) within Regeneron.
• Lead execution and implementation of Regeneron CDx strategy in collaboration with key partners.
• Evaluate and make decisions on technologies and vendors as needed to support diagnostic and program deliverables.
• Provide testing site implementation and oversight for CDx programs from contracting to sample logistics to data delivery.

This role may be for you if :

• You possess strong leadership tendencies, ability to proactively identify problems, determine resolutions, set priorities, and direct projects and work cross-functionally to manage expectations with excellent communication and collaborative skills and work well in a team-based environment.
• You demonstrate strong leadership skills and possess high level of emotional intelligence and effectively work collaboratively with colleagues, vendors and internally at Regeneron to ensure program success.
• Leads team members in representing Regeneron and working with colleagues from allied companies to develop and implement Precision Medicine CDx strategies.

To be considered for this role, you must have a Ph.D. and / or M.D Minimum of 10 years postdoctoral experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.

Extensive experience in diagnostic development with demonstrated success in a drug development setting. We need a strong understanding of technical, regulatory, clinical, and strategic aspects diagnostic delivery required.

We are seeking CDx knowledge, demonstrated deep knowledge in science and technology. Demonstrated experience in delivering diagnostics.

Contributes to and reviews documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling and participates as appropriate in internal and external meetings.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

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

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