The Diagnostic Strategy Lead (CDxSL) within the Early Clinical Research and Experimental Medicine group will lead companion and complementary diagnostic development for assigned early and late development programs across multiple therapeutic areas including Immunology and Inflammation, Ophthalmology, Cardiovascular and Metabolic Disease and General Medicine. We are seeking a candidate to guide the development of strategies for patient selection/stratification and subsequently lead the implementation/execution of diagnostic assays (including assay development, analytical validation, implementation in clinical trials, global health authority submission strategy etc) in collaboration with internal and external partners/IVD manufacturers and central testing laboratories. Experience in supporting gene therapy programs using AAV vectors is considered of particular interest for this role.
As an Associate Director in Precision Medicine, a typical day may include the following:
This role may be for you if:
Identify innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs to ensure program success
Design and author clinical trial protocol language to support the selection of patients and ultimately clinical claims for diagnostic tests, oversee operational aspects of CDx clinical trial implementation, manage timelines with internal and external partners
Work in collaboration with CDx regulatory/commercial team from program inception to global health authority marketing approval
Be viewed as a subject matter expert in companion and complementary diagnostic development and able to effectively communicate with clinical study teams on program direction
Help define CDx strategy and effectively gain alignment across relevant stakeholders (including senior management) within Regeneron
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
Develop strong working relationships with IVD partners and testing laboratories, guide and review assay validation packages, testing lab clinical trial conduct (under CAP/CLIA) and support audits of CDx testing laboratories
Excellent written and verbal communication skills are essential, experience working on cross functional teams and the ability to successfully present complex strategies
You are able to drive strategy and or projects and bring new insights to the team
To be considered for this role, you must have a Ph.D. or equivalent experience. Advanced degree strongly preferred. Minimum 7-8 years pharma/biotech or diagnostics industry experience. Technical understanding and scientific expertise in the global diagnostic landscape, including in one or more existing/emerging technologies (NGS, IHC, ELISA, FISH etc) and commercial implementation considerations for patient selection assays to help drive innovation in CDx strategy. Must have experience in execution of clinical trials, sample logistics and data reporting. Must have at least 4 years of diagnostic development experience directly supporting drug development and demonstrated working knowledge and program leadership in this space. We are need experience in biomarker discovery and development would be considered beneficial as well.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$165,900.00 - $270,700.00