Director, Digital Medicine, Clinical Sciences

Found in: Talent US C2 - 7 days ago

Tarrytown, United States Regeneron Pharmaceuticals, Inc Full time

As a Director, Digital Medicine at Regeneron, reporting to the VP, Clinical Sciences, you will play the lead role in driving digital biomarker strategy for clinical development programs. The mission is to transform the landscape of drug trial outcome measures by directly quantifying patient function in a real-world setting. Contribute to the digital biomarker strategies to support the Regeneron clinical development pipeline. Progress digital biomarker development projects through concept identification, device landscape scoping, device selection and endpoint development strategy. Design and conduct technical and clinical validation studies in patients. The long-term objective will be to qualify digital sensor parameters into digital endpoints to inform internal Regeneron decision making in proof-of-concept therapeutic trials.

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

Lead the development and implementation of a program-level digital medicine strategy aligned with the indications and potential clinical effects of Regeneron’s pipeline of innovative medicines

Ability to conceptualize the relationship between patient function and symptoms

Contribute to Regeneron’s mission to advance the field of digital medicine and identify new opportunities for innovation related to advancements; Maintaining an active collaborative network with external leaders in the field

Collaborate with cross-functional team members in Regeneron; Clinical Therapeutic Area leaders, Patient Innovation Laboratory & Operations leaders, Biostatistics, Quantitative Science leaders across Global Development and Regeneron Genetics Center, Patient-Centered Outcomes Research, Digital Technology, Engineering Services, Precision Medicine, and Imaging

Evaluate digital sensor technologies potentially capable of measuring relevant patient function across a broad disease portfolio; Evaluate existing device verification and validation data for selected sensor technologies, perform gap analyses and studies to further validate digital biomarkers in specified patient populations

Lead in the development and execution of studies to generate digital biomarkers from sensor data and implement them into drug development programs, developing them into trial endpoints

Seek input from physician-scientist disease area experts, provide context to quantitative scientists developing advanced statistical and computational methods to analyze large- and mid-scale digital biomarker datasets

Collaborate with bioinformatics and artificial intelligence/machine learning data science teams in development of novel methods for sensor data exploration and biomarker discovery

This role may be for you if:

Excellent communication skills, both written and verbal, with the ability to optimally communicate complex scientific concepts to diverse, cross-functional collaborators and senior management

Passionate about revolutionizing healthcare and want to transform Regeneron’s approach to drug development, we invite you to apply for the opportunity to join our dynamic team

To be considered for this role, you must have a Ph.D + 8 years of experience in a relevant scientific field (e.g., translational research, biomedical engineering, bioinformatics, biological science) or M.D. with both board certification and a track record of digital medicine research. 3 + years of experience in digital biomarker science (in a related field such as molecular biomarker or imaging sciences) within the pharmaceutical, biotechnology industry, or academia (post-doctoral/clinical fellowship level, 5+ years) in the digital biomarker field. Additionally, we need an individual with a proven publication record. We are seeking a strong understanding of regulatory requirements and industry standards related to digital biomarkers and devices, qualification of digital endpoints and clinical research. We require an understanding of clinical disease functional conceptualization, digital health technologies for ecological data collection, quantitative sciences, and the process of biomarker development. Additionally, fit-for-purpose qualification depending on context-of-use, including specific regulatory requirements (including medical devices and endpoint validation).

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