Associate Director, Digital Health Technologies

Build our future together:

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 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 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.

Salary Range (annually)

Required Experience:

Director