Operations

• Define and implement global biomarker and diagnostic operations strategy aligned with portfolio priorities and precision medicine objectives.
• Drive operational frameworks for biomarker assay development, validation, and deployment in clinical trials.
• Lead global cross-functional teams to integrate biomarker strategies into clinical programs.
• Oversee and coordinate all operational aspects of early biomarker development and companion diagnostic implementation in clinical trials for assigned programs.
• Ensure compliance with global regulatory requirements, ICH GCP, GLP, and quality standards for biomarker and diagnostic deliverables.
• Provide direction and oversight of biomarker & diagnostic assay work performed at external CROs and service laboratories.
• Working with both internal and external stakeholders to ensure data delivery is on-time to support project requirements and R&D innovation.
• Proactively identify trends and develop/implement solutions to maintain operational excellence.
• Identify and foster critical collaborations with strategic partners, vendors, and external collaborators.
• Evaluate, select, and develop strategic partnerships to position the organization for future business needs.
• Effectively influence across global teams and within a highly matrixed environment.
• Recruit, manage, and provide leadership and strategic direction for the global diagnostic operations team.
• Establish internal working groups to develop best practices and operational solutions.
• Foster a culture of accountability, innovation, and continuous improvement.
• Responsible for high level oversight of biomarker timelines, budgets, resources, and vendors for key programs and project deliverables.
• Works closely with J&J Procurement, Legal and Business Development to structure and execute strategic biomarker and Dx master and partnership agreements.
• Develop and maintain strong relationships with internal and external stakeholders.
• Provide expert biomarker and diagnostic development input into required clinical documents such as protocols, ICF, IB and lab manuals.
• Communicate progress, challenges, and changes that may impact timelines to senior leadership.

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Senior Director, Global Head – Biomarker & Diagnostic Operations, Oncology