Director, Precision Medicine, Companion Diagnostics
3 days ago
We are seeking a highly skilled Director to lead our Precision Medicine team in the development of Companion Diagnostics strategies.
The ideal candidate will have a strong background in immunohistochemistry (IHC) and experience in leading cross-functional teams to deliver innovative diagnostics solutions.
Key responsibilities will include guiding strategy for patient selection/stratification, leading implementation and execution of CDx assays, and collaborating with partners/IVD Sponsors and central testing laboratories.
The Director will also be responsible for developing strong relationships with IVD partners and testing laboratories, overseeing operational aspects of CDx clinical trial implementation, and communicating effectively both externally and internally.
Additionally, the Director will have a solid understanding of regulatory requirements (including IVDR) and support regulatory teams surrounding CDx (from study set up to PMA filing).
The ideal candidate will have a Ph.D. and/or M.D. with a minimum of 10 years postdoctoral experience in a 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 is required.
The Director will contribute to and review documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling and participate as appropriate in internal and external meetings.
Regeneron Pharmaceuticals 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
Salary Range (annually): $198,000.00 - $330,000.00
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