Director of Product Engineering

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EDETEK Inc.

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201 - 500 employés

Fondée en 2009

💊 Pharmaceutique

🧬 Biotechnologie

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. est une entreprise d'informatique de développement clinique qui propose un écosystème cloud-natif pour la R&D et une plateforme eClinical intégrée pour soutenir les essais cliniques et les soumissions réglementaires. Son portefeuille de produits comprend les outils d'orchestration et de collaboration CONFORM™, une suite eClinical (CTMS, EDC, ePRO/eCOA, RTSM), des hubs d'intégration de données et de métadonnées, un lac de données cliniques et des environnements prêts pour le calcul statistique et les soumissions. EDETEK offre également des services – biostatistiques et programmation, gestion des données cliniques, développement d'études cliniques, rédaction médicale et opérations eClinical – ciblant les sponsors en pharmacie, biotechnologie et dispositifs médicaux. L'entreprise met l'accent sur l'interopérabilité, la qualité des données et les capacités activées par l'IA pour accélérer l'exécution des études et les soumissions réglementaires à l'échelle mondiale.

Description

• Lead and scale the product engineering organization responsible for EDETEK software products supporting eClinical, Clinical Informatics, data integration, review, analytics, and biometrics workflows. • Provide technical and organizational leadership to multiple engineering teams, including software developers, architects, engineering managers, and technical leads. • Define and execute engineering strategy, technical roadmap, delivery model, and resource plans aligned with company product goals and business priorities. • Oversee software architecture, system design, coding standards, release management, performance optimization, maintainability, and technical debt reduction. • Drive the design and development of enterprise-grade platforms and applications using modern software engineering practices and secure SDLC processes. • Serve as a senior technical leader with strong understanding of Java-based enterprise application development, SAS-based clinical and statistical programming environments, and R-based analytical and data science workflows. • Partner closely with Product Management, Biometrics, Clinical Data Management, Statistical Programming, Regulatory, and Operations teams to translate domain and client requirements into scalable technical solutions. • Support development of products and capabilities relevant to clinical trial technology, including areas such as EDC, data integration, clinical data review, SDTM, ADaM, TLF generation, analytics, reporting, and regulatory-supporting workflows. • Ensure software solutions are designed and maintained in accordance with relevant requirements for security, privacy, auditability, validation readiness, and quality in regulated environments. • Establish and track engineering KPIs, quality indicators, delivery metrics, and team performance measures to improve predictability and execution. • Build, mentor, and retain high-performing engineering teams. Develop managers and senior contributors and create a culture of ownership, collaboration, accountability, and continuous improvement. • Lead hiring, workforce planning, organizational development, and performance management for the engineering function. • Collaborate with QA and Validation teams to ensure appropriate documentation, testing discipline, traceability, and readiness for internal and external audits. • Partner with Cloud Engineering, DevOps, and Security teams to strengthen platform reliability, scalability, observability, disaster recovery, and operational support. • Guide investigation and 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.

🎯 Exigences

• 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 deeply in system architecture, design review, technical problem solving, and engineering strategy. • Solid experience in the life sciences industry, particularly in organizations developing and supporting eClinical, Clinical Informatics, biometrics, clinical data, or regulatory-supporting software solutions. • Prior experience with or in companies comparable to Medidata, Veeva, Medpace, or other clinical technology providers is strongly preferred. • Proven success delivering complex, enterprise-scale software platforms with demanding 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.

🏖️ Avantages

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program