Accountabilities
In this role, you will provide strategic, technical, and organizational leadership across the product engineering function, ensuring the successful development and ongoing evolution of enterprise-grade software solutions.
- Lead and scale engineering teams responsible for eClinical, Clinical Informatics, data integration, clinical data review, analytics, and biometrics products.
- Provide leadership and direction to software developers, architects, engineering managers, and technical leads across multiple teams.
- Define and execute the engineering strategy, technical roadmap, delivery model, and resource plans in alignment with product objectives and business priorities.
- Oversee software architecture, system design, coding standards, release management, performance optimization, maintainability, and technical debt reduction.
- Guide enterprise application development using Java, SAS-based clinical and statistical programming environments, and R-based analytical and data science workflows.
- Partner with Product Management, Biometrics, Clinical Data Management, Statistical Programming, Regulatory, and Operations teams to translate business and client requirements into scalable technical solutions.
- Support the development of clinical trial technology capabilities, including EDC, data integration, clinical data review, SDTM, ADaM, TLF generation, analytics, reporting, and regulatory-supporting workflows.
- Ensure products meet relevant security, privacy, auditability, validation-readiness, and quality requirements in regulated environments.
- Establish and monitor engineering KPIs, quality indicators, delivery metrics, and team performance measures to improve execution and predictability.
- Build, mentor, and retain high-performing engineering teams while developing managers and senior technical contributors.
- Lead hiring, workforce planning, organizational development, and performance management across the engineering function.
- Collaborate with QA and Validation teams to maintain appropriate documentation, testing discipline, traceability, and audit readiness.
- Work with Cloud Engineering, DevOps, and Security teams to strengthen platform reliability, scalability, observability, disaster recovery, and operational support.
- Lead the investigation and resolution of critical technical issues, customer escalations, and production support challenges.
- Promote engineering excellence through Agile practices, CI/CD, test automation, code reviews, documentation, and secure software development processes.
- Foster a culture of ownership, accountability, collaboration, transparency, continuous learning, and high-quality delivery.
Requirements
The ideal candidate combines extensive software engineering experience with proven leadership capabilities and a strong understanding of clinical technology and regulated software environments.
- Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, or a related field; an advanced degree is preferred.
- At least 12 years of progressive software engineering experience, including significant leadership responsibility within product development organizations.
- At least 5 years of experience leading large engineering teams, including multiple teams and/or engineering managers.
- Strong technical expertise in Java, SAS, and R, with the ability to contribute to architecture discussions, design reviews, and engineering strategy.
- Significant experience in the life sciences industry, particularly within organizations developing or supporting eClinical, Clinical Informatics, biometrics, clinical data, or regulatory-supporting software solutions.
- Experience with clinical technology providers or comparable organizations, such as Medidata, Veeva, or Medpace, is strongly preferred.
- Proven track record of delivering complex, enterprise-scale software platforms with demanding scalability, reliability, security, and compliance requirements.
- 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 requirements in regulated environments.
- Demonstrated ability to lead globally distributed teams and collaborate effectively across technical and business functions.
- Excellent communication, leadership, stakeholder management, and strategic planning skills.
- Strong technical judgment and the ability to balance business priorities with sustainable architecture and long‑term platform health.
Preferred Qualifications
- Experience with eClinical and Clinical Informatics platforms, including EDC, CTMS, RTSM/IWRS, eCOA, eConsent, safety systems, data review platforms, integration hubs, or regulatory analytics tools.
- Familiarity with clinical trial data standards and biometrics workflows, including SDTM, ADaM, TLFs, metadata‑driven design, and statistical reporting processes.
- Experience supporting products used in regulated clinical trial environments, with requirements for traceability, controlled releases, and validation support.
- Experience with AWS or other major cloud platforms.
- Experience modernizing legacy systems and leading enterprise platform transformation initiatives.
- Familiarity with enterprise integration and API‑first product architecture.
Benefits
- Choice of comprehensive medical, dental, and vision insurance plans.
- Paid vacation time and sick days.
- Annual corporate holidays.
- Participation in the 401(k) retirement savings plan.
- Access to comprehensive perks and discount programs covering AAA, wholesale shopping, insurance, prescription services, fitness, pets, entertainment, and more.
- Access to Health Advocate services and an Employee Assistance Program.
- Fully remote position open to candidates based in the United States.