The Associate Director Digital Health Technology (DHT) leads the strategic management of one or more COA (Clinical Outcome Assessment) and DHT programs. This individual owns operational decisions instrument selection, validation, debriefing, translation, DHT planning, vendor onboarding and oversight, quality, timelines, and budgets for COA and DHT activities within assigned programs, in accordance with applicable regulations, ICH/GCP standards, and company SOPs. The role serves as a cross-functional liaison, raising awareness of Regeneron-specific COA/DHT/data integration needs, and provides oversight at both the clinical development unit/program level and the individual study level for eCOA and DHT technologies (e.g., wearables, sensors, ECG, spirometry). As the Subject Matter Expert, this person advises study teams on best practices to ensure regulatory compliance and data quality, manages vendor performance at the program level, and holds line management responsibility for staff recruitment, development, coaching, mentoring, and performance management.
When & Where
Primary Location: Warren, NJ
May require up to 25% travel
Discover Your Role
Program & Study Oversight
Accountable for the successful, compliant delivery of eCOA and DHT (wearables, sensors, ECG, spirometry) across assigned clinical programs
Executes the COA/DHT development process study design, execution, change control, and database lock activities
Owns the overall success of COA/DHT development and strategy within assigned clinical development unit(s)/program(s)
Maintains visibility into program status and issues; proactively communicates progress, risks, and changes affecting quality, timelines, or budget
Reviews key metrics and KPIs across studies to track progress and vendor performance
Ensures inspection readiness throughout the clinical program lifecycle
Planning & Setup
Leads the Program Planning and Setup phases of eCOA/DHT, including:Guiding COA/DHT and digital endpoint selection through team collaboration and literature review
Supporting Health Economics Outcomes Research (HEOR) with instrument development
Overseeing cognitive debriefing, psychometric validation studies, and DHT verification, validation, and usability activities
Provides input during protocol development to ensure consistency across the program
Provides operational insight into COA/DHT selection, vendor options, timelines, and cost estimates during program/study development
Vendor Management
May own vendor relationship management, including:Vendor selection and maintenance
Participation in vendor governance/oversight meetings
Review, negotiation, and standardization of vendor contracts and budgets with procurement
Establishing vendor performance metrics and reviews
Delivering standard vendor/sponsor expectations and operational processes
Acting as the point of contact for trial-specific and vendor-related escalations, ensuring preventative actions are implemented
Participates in eCOA, DHT, and translation vendor governance meetings as needed
Problem Solving & Risk Management
Applies problem-solving strategies and maintains issue-tracking documentation to monitor progress and ensure timely resolution
Proactively creates and implements risk mitigation strategies
Provides innovative, flexible COA/DHT solutions and scenario planning for cross-functional teams
Drives decision-making by integrating all COA/DHT operational considerations to ensure program goals are attainable before implementation
Acts as the point of contact for program- and study-level escalations
Resourcing & Continuous Improvement
Responsible for COA/DHT resource forecasting and allocation across clinical studies/programs
Identifies and recommends changes to practices and policies; initiates and participates in strategic and continuous improvement projects within Global Development
Utilizes AI as applicable to improve quality, efficiency, and effectiveness of process and product development
People Leadership
Directly supervises COA/DHT staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training/compliance, and study support oversight
This Role Requires
Knowledge & Technical Skills
Demonstrated knowledge of COA and DHT systems development processes, including wearables, sensors, ECG, and spirometry
Understanding of relevant industry trends in digital health technologies and digital endpoints
Ability to apply AI and automation to improve DHT/eCOA processes and products
Working knowledge of GCP and ICH guidelines
Extensive experience in global clinical trial operations
Leadership & Interpersonal Skills
Strong interpersonal and leadership skills
Ability to provide strategic direction and guidance for clinical programs
Ability to influence and negotiate
Ability to build productive teams and collaborations
Line Management Experience With Demonstrated Mentoring And Coaching Skills
Operational & Analytical Skills
Analytical, data-driven approach to planning, executing, and problem-solving
Strong project management, cross-functional leadership, and organizational skills
Budget management experience
Demonstrated vendor management experience
Effective communication skills verbal, written, and presentation
Work Style
Proactive and self-disciplined; able to meet deadlines, manage time effectively, and prioritize
Education
Education: Bachelors degree required; MBA preferred
Experience: Minimum of 10 years of relevant industry experience
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
