Director, Digital Biomarker Lead

$176,900 - $294,800/Yr

Regeneron Pharmaceuticals - Sleepy Hollow, NY

Full-time - Senior

Sleepy Hollow, NY

Professional, Scientific, and Technical Services

About the position

We envision a future where innovative digital biomarker endpoints accelerate the translation of Regeneron's breakthrough discoveries to novel treatments that enhance patient lives. As a Digital Biomarker Lead reporting to the Head of Digital Health Technologies, you will play a pivotal role in developing and incorporating digital biomarkers within clinical programs and revolutionizing clinical research at Regeneron. This innovative position bridges the gap between traditional biomarkers and cutting-edge digital technologies, driving the development and validation of novel digital endpoints for clinical trials. In this role, a typical day might include navigating the landscape of wearable sensors and digital tools, designing innovative studies to understand patient mobility and physiology in groundbreaking ways. From EEG to eye trackers, you'll assess and implement these technologies, aiming to improve trial efficiency and reduce patient burden. You will champion strategic partnerships with sensor providers, research institutions, and internal stakeholders. By fostering collaboration and navigating regulatory pathways, you'll lead the development and implementation of verification and technical validation of novel digital endpoints, shaping the future of clinical research. As a Digital Biomarker Lead, you will oversee aspects of sensor-related research, from benchtop experiments to oversight of technical validation in large-scale clinical trials. This role will have direct reports and will be responsible for shaping the next generation of digital biomarker experts by providing mentorship to the careers and personal growth of your talented team. This is a role for passionate and curious individuals. If you thrive on scientific exploration, possess exceptional leadership skills, and dream of using technology to revolutionize healthcare, then this may be the right fit for you.

Responsibilities

• Conduct landscape reviews to identify novel digital biomarkers aligned with asset development needs.
• Develop and validate new ways to understand patient mobility and physiological processes through wearable digital technologies (e.g., inertial sensors, eye-trackers, EEG, etc.).
• Identify candidate sensor technology and candidate endpoints to reflect functional concept, create a plan for human studies (Verification/Pilot, Validation/CES, Interventional trials), including assembling a Digital Biomarker team.
• Establish collaboration and build vendor relationships with fit-for-purpose digital sensor providers and tech R&D companies.
• Design benchtop studies and work with Digital Biomarker lab engineers to obtain Regeneron data on device performance and report results.
• Identify context-specific gaps and design and execute verification in healthy volunteers & patients with respect to technical validation & usability.
• Provide input to analysis plans written by Quantitative Science (QS) to analyze data from pilot studies and identify and synthesize the relevant literature to inform meaningful change with relevant benchmarks.
• Liaise with Regulatory Affairs, Digital Medicine, Patient Centered Outcome Research, and QS on developing endpoint qualification strategy for technical validation.
• In collaboration with medical director, Digital Medicine Lead, QS, and others, design study; execute on sensor-facing aspects of CES study, including liaison with vendor/device collaborator and User Experience Research (UXR).
• Lead on digital & device-facing aspects of study: protocol, usability, tech validation, training, delivery and implementation, data transfer (in liaison with Sci Data Enblmt).
• Provide device/sensor input to analysis plans written by Quantitative Sciences (QS) on the technical validation aspects (accuracy, reliability, reproducibility, and validation against reference standard) in the clinical population and establish technical validation strategy.
• Contribute from aspects of verification, technical validation, and usability aspects of V3 framework (Verification, Technical & Clinical Validation).
• Lead on device-facing aspects of study: training, delivery, and implementation, data transfer (in liaison with Scientific Data Enablement).
• Maintain an in-depth understanding of industry trends and opportunities through qualitative research, insights, and market analysis.
• Continuously pursue new opportunities that benefit clinical trials and present solutions to internal stakeholders.
• Lead collaborations with internal stakeholders and vendors to strategize effective innovative solutions.
• Create business cases, develop hypotheses, plan pilot and concept testing, and execute surveys to progress innovative strategies at a trial, program, or corporate level.
• Develop global best practices to support adoption of different innovation technologies.
• Set qualification requirements for new vendors supporting innovations.
• Support and monitor financial components related to Innovation for each study.

Requirements

• Knowledge of technologies and services available in a clinical setting
• Demonstrated knowledge of general system development processes
• Demonstrated interpersonal & leadership skills
• Understanding of the digital medicine field and clinical drug development
• Strong scientific background in digital biomarker research
• Proven knowledge of or experience with clinical trial development process and use of clinical technologies
• Ability to understand and implement the strategic direction and guidance for respective clinical studies
• A data driven approach by planning, gathering information, mitigating risks, and executing
• Effective communication skills (verbal, written and presentation abilities)
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• An awareness of relevant industry trends
• Knowledge of ICH/GCP and regulatory guidelines/directives
• Effective project management skills, cross-functional team leadership and organizational skills
• Masters Degree required with minimum of 12 years relevant industry experience OR PhD (preferred) with minimum 8+ years of relevant industry experience.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees at all levels