Executive Director, Translational and Clinical Informatics

The Opportunity:

We are seeking an Executive Director, Translational and Clinical Informatics to lead and grow the informatics function supporting Translational Research, preclinical development and clinical data science. You will oversee strategy, execution, and delivery of informatics solutions that enable scientific insight, accelerate timelines, and ensure high-quality data and analytical results from research into clinical execution.

Key responsibilities include:

• Own the informatics strategy and portfolio for Translational Science, Nonclinical Development & Clinical Pharmacology and Quantitative Sciences.

• Lead, develop and mentor a high-performing team of informatics professionals and manage external vendors and partners.

• Translate scientific and business needs into innovative and practical informatics strategies that align end-user scientists, partner informatics teams and enable rapid execution.

• Oversee the full lifecycle of informatics platforms including requirements, vendor selection, implementation, validation (where needed) and support.

• Drive adoption of modern cloud, data and AI-enabled technologies to accelerate scientific insight and decision-making.

• Serve as the primary informatics partner to senior scientific and development stakeholders.

• Ensure systems meet applicable GxP, data integrity and compliance requirements.

• Apply a holistic, enterprise view encompassing people, process, data, technology, science, compliance and finance to deliver informatics solutions that solve real business problems efficiently.

Required Skills, Experience and Education:

• BS/MS/Ph.D. in Computer Science, Software Engineering, Research Informatics, Bioinformatics, Cheminformatics, or a related field.

• Significant experience in scientific informatics or data engineering within biotech or pharmaceutical R&D, with a minimum of 18+ years of relevant experience with a Bachelor’s degree, 16+ years of relevant experience with a Master’s degree or 13+ years of relevant experience with a Doctoral degree.

• Demonstrated success building, leading and scaling informatics organizations and managing strategic vendor partnerships.

• Deep understanding of drug development across translational science, biomarkers, nonclinical development, clinical pharmacology, preclinical safety and clinical data management.

• Experience deploying and managing on-prem/cloud hybrid informatics solutions in AWS or Azure.

• Strong understanding of relational databases and data lakehouse platforms such as Databricks.

• Demonstrated success owning the end-to-end lifecycle of scientific informatics platforms, from requirements gathering to build/buy to implementation and long-term support.

• Experience developing AI or AI-enabling applications supporting drug development.

• Strong understanding of data model design, scientific data integration and data visualization best practices.

• Experience with statistical programming languages such as SAS and R.

Preferred Skills:

• Strong understanding of translational data types such as pathology, preclinical animal models patient biomarker data.

• Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation approaches. 

• Familiarity with clinical data platforms such as CTMS, EDC, eTMF, and IRT/RTSM systems. 

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