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Associate Director, Process Development Lead – Data Science

United States – RemoteClinical Development & Clinical OperationsRegular

Job Description

Associate Director, Process Development Lead – Data Science:

Recently, Gilead launched an Enterprise Data Science Council (EDSC), serving as a central hub to enable and coordinate enterprise-wide data science activities, establish enterprise policies related to Data Governance and AI, and provide visibility into use case investments across the company. The Process Development Lead will be responsible for designing, implementing, and optimizing processes that support the functioning of the EDSC. The position requires high proficiency in process development, proven ability to deliver results, and an understanding of data science (e.g., enterprise data governance and AI governance). The candidate will collaborate with data engineers, scientists, and other leaders to draft well-defined data usage policies, standards, and procedures align with organizational goals and regulatory requirements. The role involves continuous monitoring and improvement of data governance processes to enhance data quality, integrity, security, and compliance across the enterprise.

Key Responsibilities will include, but are not limited to the following:

  • Lead the development and maintenance of enterprise data science (e.g., data governance and AI governance) procedural documents, process maps, and community-based materials to support EDSC objectives.
  • Facilitate communication and collaboration across teams to align process development with EDSC objectives.
  • Ensure processes comply with relevant regulations and standards (e.g., FDA, EMA) and comply with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
  • Work closely with representatives from Research and Development, Manufacturing, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless process integration and change management.
  • Coordinate with functional training groups to develop training programs that support council objectives.
  • Monitor and report on the effectiveness of data governance and AI governance processes.
  • Provide expertise in AI governance to ensure responsible and ethical use of AI technologies.
  • Support R&D Quality functions during audits and assessments to identify and mitigate data risks.

Qualifications

  • 8+ Years with MS/MA or MBA
  • 10+ Years with BS/BA
  • 2+ Years with a PhD
  • Passionate about continuous improvement within the field of data science and establishing new procedures which embrace technological solutions and/or automation via advanced data solutions.
  • Mature experience and skillsets in developing process maps and authoring technical and scientific literature.
  • Excellent writing skills including translating complex subject matter into lucid and comprehensible terms.
  • Critical thinking ability to connect themes and concepts from diverse teams to build controlled procedures.
  • Strong analytical skills to assess data quality issues and develop solutions to improve processes.
  • Strong communication skills to articulate data governance concepts and policies to non-technical audiences.
  • Able to quickly pivot to emerging and changing needs of the EDSC.
  • Experience managing complex projects and working with cross-functional teams.
  • Proven track record of developing and implementing data governance frameworks and policies.
  • Ability to analyze the impact of data governance policies on business processes.
  • Knowledge of data governance principles, AI governance principles, and relevant data protection regulations.
  • Experience and knowledge in the field of technology, clinical or data sciences.
  • Understanding of pharmaceutical regulations and guidelines (e.g., FDA, EMA, GxP, HIPAA).