Associate Director, Digital Health Technologies

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

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

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: Bachelor’s degree required; MBA preferred
• Experience: Minimum of 10 years of relevant industry experience