- 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.
- 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.
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Director, Digital Biomarker Lead - Armonk, United States - BioSpace
Description
Job DetailsWe envision a future where innovative digital biomarker endpoints accelerate the translation of Regenerons breakthrough discoveries to novel treatments that enhance patient lives. As a Digital Biomarker Lead reporting to Head of Digital Health Technologies you will be 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 be overseeing aspect 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 the passionate and curious talented 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.
This role might be for you if can:
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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)
$176, $294,800.00
