Associate Director, Digital Health Technologies

Regeneron Pharmaceuticals, Inc (USA); Kentucky; On-site; USD 157,000 - 257,000; Full time

Benefits offered by this job

Annual bonuses or incentives

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits (medical, dental, V

Life and disability insurance

Paid time off

Family support benefits

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks an Associate Director to lead COA and Digital Health Technology programs, ensuring compliant, timely delivery across clinical development units. You will manage instrument selection, validation, vendor oversight, budgets, and data quality, while mentoring staff and aligning with ICH/GCP standards.

The role requires 10+ years in clinical operations, strong leadership, and deep COA/DHT knowledge, with on-site work in Warren, NJ and up to 25% travel.

Qualifications

• Bachelor’s degree required; MBA preferred.
• Minimum 10 years of relevant industry experience.
• Strong leadership, mentoring and coaching capabilities.
• Experience with COA/DHT, wearables, ECG, spirometry.

Responsibilities

• Accountable for successful, compliant delivery of COA/DHT across clinical programs.
• Lead study design, execution, changes, and database lock activities.
• Oversee vendor governance, budgets, and performance metrics.
• Provide risk management, issue-tracking, and contingency planning.
• Direct COA/DHT resource forecasting and cross-functional coordination.

Skills

COA/DHT knowledge

Leadership & people mgmt

Project management

Analytical / data-driven

Budget management

Vendor management

Regulatory compliance (GCP/ICH)

Cross-functional collaboration

Strategic planning

Communication skills

Education

Bachelor’s degree

MBA

Job description

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.

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

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
• 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.

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 on‑site.

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) $157,200.00 - $256,600.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.