This role requires you to work onsite in a hybrid model out of our Tarrytown, NY or Basking Ridge, NJ office. If a candidate is not local and meets Regeneron's relocation eligibility, a package will be provided.
The Associate Director, Digital Biomarker Lead will handle assessment and validation of novel digital technologies to increase clinical trial effectiveness and reduce trial burden to the patient for Regeneron’s clinical research trials.
In this role, a typical day might include:
Providing support for the patient innovation laboratory, primarily related to physiological and biomechanical measurement of healthy and clinical groups. This will include synchronization of equipment, operating and troubleshooting specialized laboratory equipment, development of analysis codes and pipelines, data processing, report generation, as well as support for data collection. They will additionally perform quality control, troubleshoot and formally document quality checking of all motion and physiological data collection equipment/procedures, for all clinical and research studies in collaboration with the Patient Innovation team. The Associate Director may have responsibilities for developing and delivering fit-for-purpose solutions to meet the needs of the Regeneron portfolio. The Associate Director requires strong analytical and research skills, presentation skills, creative thinking and problem-solving skills, and experience with the device verification and validation process to develop digital biomarkers. Functions as Subject Matter Expert (SME) advising internal clinical study teams on best practices in technology adoption to ensure regulatory compliance and data quality. The Associate Director will be expected to liase with internal and external collaborators, identify and drive external alliances and ventures under the supervision of the Sr. Director, Clinical Outcomes Assessment & Innovations.
This role might be for you if can:
Be responsible & accountable for the assessment and successful delivery of new technologies, methodologies or services for one or more clinical research trials with quality and compliance
Conduct landscape reviews to identify novel digital biomarkers aligned with asset development needs
Develop and validate new ways for understanding patient mobility and physiological processes through wearable digital technologies (e.g., inertial sensors, eye-trackers, EEG, etc.)
Responsible to lead the implementation of digital biomarkers in clinical trials
Maintain an in-depth understanding of Industry trends and opportunities, through qualitative research and insights, and market analysis
Continuously pursue new opportunities that may benefit clinical trials and present solutions to internal stakeholders
Experiment with research methods, processes and instruments
Expand use of wearables:
Identify new ways for understating patient functional mobility impact through wearables
Collect objective data through wearables/sensors in support of existing self reported data
Introduce structured group ideation sessions to:
Identify and pursue new opportunities to advance clinical trials
Propel research of new technologies based on program needs
Maintain cutting edge knowledge of developments in clinical measurements, latest innovations, clinical trial industry news, and advancing regulatory trends through conference attendance, open forums and developing external relationships
Partner with leading institutions in research (startups, academia, CRO) to collaborate on concept development and new technology adoption
Communicates with internal stakeholders to understand clinical trial needs and areas of opportunities
Lead collaborations with internal stakeholders and vendors to strategize effective innovative solutions
Provide input into protocol development as it relates to sensors or other clinical technologies
Create business cases, develop hypothesis, plan pilot and concept testing, execute surveys to progress innovative strategies at a trial, program or corprorate 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
Collaborate with key internal stakeholders, including statistics and data management on data specifications, standards, and transfers
Identifies and recommends changes to practices and policies, including initiating and participating in strategic projects, initiatives, and continuous improvement projects within Global Development
Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
Facilitates and contributes to study level lessons learned
Recommends and participates in cross-functional and departmental process improvement initiatives
May be Responsible for direct supervision of staff
May require up to 25% travel
To be considered for this opportunity, you must have the following:
MS with 8 years of relevant experience
Demonstrate 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 technolgoies
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
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