Associate Director, Digital Health Technologies

Regeneron

. Lead the strategic management of one or more COA and DHT programs .

Posted 10/13/2026full-timeWarren • New Jersey • United StatesSenior💰 $157,200 - $256,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing COA and DHT programs, ensuring compliance with regulatory standards while optimizing vendor performance and resource allocation. Proven ability to lead cross-functional teams and implement innovative solutions to enhance clinical development processes.

Highest-signal resume keywords

COA And DHT Program ManagementVendor ManagementRegulatory ComplianceClinical Trial OperationsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

COA Systems DevelopmentDHT Systems DevelopmentData Quality AssuranceBudget ManagementAI Application in DHTGCP KnowledgeICH Guidelines KnowledgeAnalytical Problem-SolvingStudy Design ExecutionRisk Mitigation Strategies

Soft Skills

Leadership SkillsInterpersonal SkillsNegotiation SkillsTeam BuildingEffective Communication

Tools & Technologies

WearablesSensorsECGSpirometryECOA Technologies

Certifications & Qualifications

Bachelor's DegreeMBA Preferred

Industry Keywords

Digital Health TechnologiesDigital EndpointsGlobal Clinical TrialsClinical DevelopmentContinuous Improvement

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the strategic management of one or more COA and DHT programs
Own operational decisions including instrument selection, validation, debriefing, translation, DHT planning, vendor onboarding and oversight, quality, timelines, and budgets
Serve as a cross-functional liaison for COA/DHT/data integration needs
Provide oversight at clinical development unit/program and individual study levels for eCOA and DHT technologies
Advise study teams on best practices for regulatory compliance and data quality
Manage vendor performance at the program level
Directly supervise COA/DHT staff, including recruitment, development, coaching, mentoring, training, and performance management
Account for compliant delivery of eCOA and DHT across assigned clinical programs
Execute COA/DHT development activities including study design, execution, change control, and database lock
Monitor program status, issues, risks, quality, timelines, budgets, metrics, KPIs, and vendor performance
Ensure inspection readiness throughout the clinical program lifecycle
Lead program planning and setup, endpoint selection, instrument development support, cognitive debriefing, validation, verification, and usability activities
Provide operational input on vendor options, timelines, and cost estimates
Manage vendor relationships, governance, contracts, budgets, performance metrics, and escalations
Create and implement risk mitigation strategies and innovative COA/DHT solutions
Forecast and allocate COA/DHT resources across clinical studies and programs
Initiate and participate in strategic and continuous improvement projects
Utilize AI to improve process and product development quality, efficiency, and effectiveness

Requirements

What you’ll need

Bachelor’s degree required
MBA preferred
Minimum of 10 years of relevant industry experience
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
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
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 verbal, written, and presentation communication skills
Proactive and self-disciplined; able to meet deadlines, manage time effectively, and prioritize

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required