Director of Product Engineering

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EDETEK Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORM™ orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services — biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations — targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.

📋 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.

🎯 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 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.

🏖️ Benefits

• 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