Senior Manager, Digital Biomarker Lead

This role requires you to work onsite in a hybrid model out of our Tarrytown, NY , Basking Ridge, NJ or UxBridge, UK office. If a candidate is not local and meets Regeneron's relocation eligibility, a package will be provided.

The Sr. Manager, 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 Regenerons 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 Sr. Manager may have responsibilities for developing and delivering fit-for-purpose solutions to meet the needs of the Regeneron portfolio. The Sr. Manager 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. This role will liaise with internal/external collaborators, identify and drive alliances and ventures under the supervision of the Associate Director, Digital Biomarker Lead. Provides oversight at program level and individual clinical research studies for Inovation aspects in collaboration with the study team. Functions as Subject Matter Expert (SME) advising internal clinical study teams on best practices in technology adoption to ensure regulatory compliance and data quality.

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 4 years of relevant experience

• Has knowledge of technologies and services available in a clinical setting\

• 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 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

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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)

$126,600.00 - $206,600.00