Director of Information Technology
The Lotus Group LLC
Director, Clinical Systems Data & Analytics
A leading global biopharmaceutical company is seeking a Director of Clinical Systems Data & Analytics to shape and deliver the technology, data, and analytics strategy supporting clinical development and R&D operations.
This is a highly visible leadership opportunity combining clinical-systems strategy, modern data architecture, technical program delivery, and organizational development. The Director will initially take a hands‑on role in assessing business needs, defining the technical roadmap, and establishing the necessary capabilities and operating structure. Over time, this individual will build and lead a high‑performing team responsible for scalable, compliant, and forward‑looking solutions across the clinical technology environment.
The position is based in the San Francisco Bay Area and follows a hybrid onsite schedule.
Responsibilities
- Define and lead the clinical operational data, systems, and analytics strategy in alignment with broader R&D and business objectives.
- Develop short- and long-term technology roadmaps for clinical platforms, data integration, analytics, and supporting infrastructure.
- Lead the design and delivery of scalable solutions across commercial and custom clinical applications, including EDC, CTMS, eTMF, and related R&D platforms.
- Oversee clinical data architecture, pipelines, APIs, ETL processes, cloud platforms, and integrations with enterprise systems.
- Partner with Clinical Operations, Clinical Data Management, Biostatistics, Quality, Validation, IT, and other stakeholders to translate business needs into effective technical solutions.
- Lead multiple concurrent, high‑complexity programs spanning clinical systems, data engineering, analytics, and process improvement.
- Establish appropriate program governance, resource plans, budgets, delivery standards, and risk‑management practices.
- Ensure technical programs are delivered on time, within budget, and in accordance with quality and regulatory expectations.
- Build and lead a high‑performing organization, including other people leaders; recruit, develop, coach, and retain talent.
- Provide hands‑on technical and program leadership during the initial assessment and organizational buildout.
- Guide solution design and serve as a senior technical and data‑strategy advisor to R&D stakeholders and technology teams.
- Partner with Quality and Validation functions to ensure appropriate testing, validation, change control, and SDLC execution.
- Maintain data integrity, system security, inspection readiness, and compliance across clinical data and analytics environments.
- Identify opportunities to improve system performance, reduce cycle times, eliminate redundancy, and scale effective practices across programs.
- Support regulatory inspections and internal audits as a senior Clinical Systems and data subject‑matter expert.
- Drive adoption of modern analytics, cloud, automation, and AI capabilities where they provide meaningful business value.
Qualifications
- Bachelor’s or master’s degree in computer science, data analytics, information systems, engineering, or a related discipline, or equivalent relevant experience.
- Approximately 12–15+ years of progressive experience in information systems, data analytics, business intelligence, or related technology functions.
- At least 10 years of experience within pharmaceutical, biotechnology, healthcare, or another highly regulated life‑sciences environment.
- Significant experience leading clinical systems, clinical data platforms, or R&D technology capabilities.
- Demonstrated ownership of complex, end‑to‑end data and analytics solutions.
- Strong understanding of clinical‑development processes and the systems supporting Clinical Operations and clinical data acquisition.
- Experience designing or overseeing data architectures involving APIs, ETL pipelines, data lakes, data warehouses, data marts, and cloud‑based platforms.
- Working knowledge of cloud ecosystems such as AWS, Azure, or Google Cloud.
- Familiarity with modern analytics and visualization platforms such as Tableau, Power BI, Looker, Qlik, ThoughtSpot, or comparable technologies.
- Experience with clinical platforms such as Medidata, Veeva, Salesforce, or comparable commercial and custom applications.
- Strong understanding of GxP requirements, computerized‑system validation, user acceptance testing, SDLC practices, data integrity, and audit readiness.
- At least eight years of direct people‑management experience, ideally including leadership of managers or other people leaders.
- Demonstrated success building teams, establishing operating models, and developing technical capabilities.
- Experience independently creating program budgets, resource plans, technical roadmaps, and delivery strategies.
- Proven ability to lead multiple complex projects and balance competing priorities across business areas.
- Executive‑level communication and influencing skills, with the ability to translate technical concepts clearly for business stakeholders.
- Strong organizational awareness, change‑management capability, and ability to influence without direct authority.
- Demonstrated coaching, talent‑development, negotiation, and conflict‑resolution skills.
- High standards for quality, accuracy, accountability, and operational execution.
The successful candidate will create an inclusive environment, connect team priorities to organizational objectives, and give employees the clarity and support necessary to succeed. This leader will actively develop talent, provide meaningful feedback and coaching, remove barriers to execution, and foster collaboration across the broader R&D and technology organization.
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