Director, Precision Medicine & Biomarker Strategy

• The Precision Medicine Director leads the development and execution of precision medicine strategies in support of clinical programs, ensuring alignment with broader disease area and global development strategies.
\n • This role operates at the intersection of clinical development, biomarker science, and diagnostics, leading cross-functional teams to design and implement biomarker strategies.
\n • The position plays a critical role in enabling patient selection, supporting regulatory submissions, and ensuring high-quality, compliant delivery of clinical and diagnostic programs.
\n • Develop and execute precision medicine strategies aligned with disease area and clinical program objectives
\n • Lead cross-functional biomarker sub-teams covering molecular epidemiology, assay development, and data analysis
\n • Serve as a core member of global clinical teams and act as subject matter expert in precision medicine
\n • Contribute to diagnostic target product profiles and companion diagnostic development strategies
\n • Identify and manage risks to ensure successful delivery of precision medicine programs
\n • Author biomarker and diagnostic sections of key clinical development documents
\n • Support regulatory submissions as a precision medicine and biomarker expert
\n • Facilitate collaborations with external academic and scientific partners
\n • Ensure compliance with applicable medical device regulations and internal quality standards
\n • Promote knowledge sharing and contribute to operational excellence and process improvement

Requirements

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• Significant experience in clinical research, clinical trials, or precision medicine within a life sciences environment
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• Proven experience leading cross-functional and multi-disciplinary teams
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• Strong understanding of biomarker strategies, companion diagnostics, and clinical development processes
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• Experience working within regulated environments and complying with global regulatory standards
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• Strong leadership, stakeholder management, and collaboration skills
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• Ability to manage risk and drive strategic decision-making
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• Experience developing clinical or regulatory documentation
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• Strong scientific and analytical capabilities within life sciences
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🔍 ATS Optimization Keywords
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Hard Skills

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• clinical research
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• clinical trials
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• precision medicine
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• biomarker strategies
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• companion diagnostics
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• clinical development processes
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• regulatory documentation
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• data analysis
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• assay development
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• molecular epidemiology
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Soft Skills

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• leadership
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• stakeholder management
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• collaboration
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• risk management
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• strategic decision-making
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• knowledge sharing
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• process improvement
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• interpersonal skills
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• organizational skills
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• communication skills
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