About the Job

The Director, Clinical Data Solutions is a senior leader and innovator responsible for defining and executing the strategic vision for customer-facing clinical data platforms, analytics, and operational solutions that enable scalable, compliant, and differentiated clinical trial and CDx delivery at FMI. This role combines department-level strategy, people leadership, and technology innovation, including the incorporation of AI-enabled tools into operational and analytic workflows.

The Director oversees senior individual contributors, partners closely with cross‑functional stakeholders, and serves as the portfolio owner for Clinical Data Solutions. This leader ensures that systems, processes, and analytics capabilities evolve in alignment with FMI’s long‑term Precision Medicine, Operations and Biopharma strategies while delivering measurable improvements in quality, efficiency, scalability, and partner experience. As part of this role, the Director will oversee the Process Data Governance to support the overall structure of Precision Medicine Solutions as well as ensuring that delivering at scale.

This role contributes to the overall development and delivery of the Precision Medicine department strategy and vision, provides insights to operations for decision making and acts as a hub for AI, technology tools, process, product and training innovation within the department.

Key Responsibilities

• Strategic & Organizational Leadership 
  • Define and own the multi‑year strategic roadmap for Clinical Data Solutions, aligning platforms, analytics, and operational capabilities with FMI priorities. 
  • Translate strategy into scalable operating models, capability roadmaps, and investment plans. 
  • Serve as a strategic advisor to senior Precision Medicine Solutions and Global Operations leaders and represent Clinical Data Solutions in governance forums. 
• Clinical Trial Solutions & External Partner Enablement 
  • Lead strategy for external‑facing clinical trial data and workflow solutions supporting profiling, monitoring, and patient identification initiatives. 
  • Partner with BioPharma, Product Marketing, and Commercial teams to define value propositions, success metrics, and adoption strategies. 
  • Review executive‑level dashboards and reports highlighting partner impact, risks, and opportunities. 
• People Leadership & Talent Development 
  • Lead and develop individual contributors, fostering accountability, leadership capability, and a culture of continuous improvement. 
  • Set vision, objectives, and success metrics aligned to enterprise strategy. 
  • Oversee workforce planning, hiring strategy, succession planning, and capability development. 
• Clinical Data Platforms, Analytics, & AI Strategy 
  • Provide executive oversight for clinical trial systems and data platforms, including reporting environments, partner portals, and CTMS. 
  • Lead AI and advanced analytics integration to enable AI‑assisted insights, process automation, and scalable solution pipelines. 
  • Navigate governance for responsible AI adoption, validation, and compliance. 
  • Apply analytics to drive efficiency, risk prediction, and strategic decision‑making. 
• Product & Portfolio Ownership 
  • Own the strategic vision and lifecycle management of the Clinical Data Solutions portfolio. 
  • Evaluate market and customer needs to guide innovation and solution evolution. 
  • Sponsor business cases for new capabilities and platform investments. 
• Operational Excellence, Business Operations, Change & Organizational Enablement 
  • Establish KPIs and dashboards to monitor quality, efficiency, forecasting scalability, and compliance for all of Precision Medicine Solutions 
  • Owning Process Data Governance for Precision Medicine Solutions partnering within the group on maintaining and support Biopharma Audit and Quality Improvement activities 
  • Sponsor and lead large‑scale change initiatives tied to new platforms, analytics capabilities, and operating models. 
  • Partner with Global Operations Office of the COO, Biopharma, Finance and HR on capacity modeling, resourcing strategy, and portfolio investment prioritization. 
  • Serve as an escalation point for complex, cross‑functional operational challenges. 
• Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Bachelor’s degree in a scientific, technical, or quantitative field (or equivalent combination of education and experience). 
• 10+ years of experience in clinical data, product management, analytics, or operational leadership within life sciences, biopharma, diagnostics, or clinical trials. 
• 6+ years of people management experience. 

Preferred Qualifications:

• Advanced degree (Master’s or PhD) in biology, statistics, data science, computer science, business, or related field. 
• Proven work experience in product or project management, especially in the pharmaceutical or diagnostic industry or a comparable position in clinical trials. 
• Demonstrated experience setting and executing organizational or portfolio‑level strategy. 
• Experience delivering external‑facing clinical trial or BioPharma partner solutions. 
• Experience integrating AI, automation, or advanced analytics into regulated clinical or operational environments. 
• Strong understanding of the drug development lifecycle and global clinical trial regulations (ICH‑GCP). 
• Proven ability to scale teams, platforms, and processes in fast‑paced, evolving organizations. 
• Exceptional stakeholder management, communication, and influence skills at the executive level. 
• Experience with operational excellence methodologies (e.g., Lean, Six Sigma) and data‑driven decision making. 
• Working knowledge of data privacy, HIPAA, and patient safety requirements. 
• Commitment to reflect FMI’s values and operating principles. 
• Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines 
• Commitment to reflect FMI’s values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $196,000 - $245,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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