Director of Product Engineering

3 weeks, 5 days ago
Full-time
Executive
Software Development
EDETEK

EDETEK

EDETEK Inc. is a premier provider of digital clinical trial systems, offering innovative solutions to streamline data collection and analysis for pharmaceutical and biotech companies.

Internet Software & Services
51-250
Founded 2009

Description

  • Lead and scale the product engineering organization supporting EDETEK software products across eClinical, Clinical Informatics, data integration, review, analytics, and biometrics workflows.
  • Provide technical and organizational leadership to software developers, architects, engineering managers, and technical leads.
  • Define and execute the engineering strategy, technical roadmap, delivery model, and resource plans aligned with product and business priorities.
  • Oversee software architecture, system design, coding standards, release management, performance optimization, maintainability, and technical debt reduction.
  • Drive design and development of enterprise-grade platforms and applications using secure SDLC and modern software engineering practices.
  • Partner with Product Management, Biometrics, Clinical Data Management, Statistical Programming, Regulatory, and Operations teams to translate requirements into scalable technical solutions.
  • Ensure software is designed and maintained for security, privacy, auditability, validation readiness, and quality in regulated environments.
  • Establish and track engineering KPIs, quality indicators, delivery metrics, and team performance measures.
  • Build, mentor, retain, and develop high-performing engineering teams and engineering leaders.
  • Lead hiring, workforce planning, organizational development, and performance management for the engineering function.
  • Collaborate with QA, Validation, Cloud Engineering, DevOps, and Security teams to improve documentation, testing discipline, traceability, reliability, scalability, observability, disaster recovery, and operational support.
  • Guide resolution of critical technical issues, customer escalations, and production support challenges.
  • Drive engineering excellence in Agile execution, CI/CD, test automation, code review, documentation, and secure development practices.

Requirements

  • Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, or a related field; advanced degree preferred.
  • 12+ years of progressive experience in software engineering, including significant leadership responsibility in product development organizations.
  • 5+ years of experience leading large engineering teams, including multiple teams or managers.
  • Strong technical background in Java, SAS, and R, with the ability to engage in architecture, design review, technical problem solving, and engineering strategy.
  • Solid experience in the life sciences industry, particularly with eClinical, Clinical Informatics, biometrics, clinical data, or regulatory-supporting software solutions.
  • Prior experience with companies comparable to Medidata, Veeva, Medpace, or other clinical technology providers is strongly preferred.
  • Proven success delivering complex, enterprise-scale software platforms with requirements for scalability, reliability, security, and compliance.
  • Experience with cloud-based environments, APIs, distributed systems, databases, CI/CD pipelines, and modern software delivery practices.
  • Strong understanding of software quality systems, validation expectations, SDLC controls, audit readiness, and compliance considerations in regulated environments.
  • Demonstrated ability to lead globally distributed teams and collaborate effectively across functions.
  • Excellent communication, leadership, and stakeholder management skills.
  • Experience with eClinical and Clinical Informatics platforms such as EDC, CTMS, RTSM/IWRS, eCOA, eConsent, safety systems, data review platforms, integration hubs, or regulatory analytics tools is preferred.
  • Familiarity with clinical trial data standards and biometrics workflows, including SDTM, ADaM, TLFs, metadata-driven design, and statistical reporting processes is preferred.
  • Experience supporting products in regulated clinical trial environments with traceability, controlled releases, and validation support is preferred.
  • Experience with AWS or other major cloud platforms is preferred.
  • Experience modernizing legacy systems and leading platform transformation initiatives is preferred.
  • Familiarity with enterprise integration and API-first product architecture is preferred.

Benefits

  • Benefits vary by country, with a competitive package offered.
  • Comprehensive Medical, Vision, and Dental insurance plans for U.S. employees.
  • Paid vacation time and sick days.
  • Corporate holidays annually.
  • Participation in the 401K plan.
  • Perks and discount programs for AAA, wholesale, insurance, prescription, fitness, pets, entertainment, and more.
  • Health Advocate and Employee Assistance Program.
  • Remote position open to candidates based in the United States.

Interested in this position?

Apply directly on the company website

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