About the Job

This role is responsible for supporting CDx evidence generation, biopharma project pipeline development, and novel biomarker definition strategy for FMI CDx and clinical trial enrollment assay programs. The incumbent mentors or supervises junior staff, builds and maintains strong collaboration with other teams across the organization to implement biomarkers for biopharma partners, and integrates clinical reporting and clinical trial expertise to ensure aligned and sustainable biomarker strategy across the FMI portfolio. This position contributes to the long-term growth strategy of the Global Operations team by participating in process improvement initiatives. 

Key Responsibilities

• Leverage scientific evidence and provide reporting insights to define fit-for-purpose biomarker approaches for use in clinical trial applications, CDx programs, and other development activities, working closely with Clinical Biomarkers Team members, other internal teams, and key biopharma partner stakeholders. 
  • Lead efforts to align longitudinal clinical reporting at FMI with emergent clinical trial and CDx biomarker strategy. 
  • Scope and evaluate the scientific rationale, intent and biomarker requirements defined in clinical trial protocols. 
  • Drive internal and external alignment around biomarker definition proposals. 
  • Work with other functional teams to implement new biomarkers in our pipeline. 
  • Solicit feedback and communicate biomarker definitions/rules and biomarker analysis results within FMI and to external stakeholders. 
• Drive execution of CDx Clinical Development Plan deliverables. 
  • Provide internal FMI functions, such as Marketing, Field Medical, Payer, and Regulatory with key data to support external messaging and stakeholder engagement. 
  • Build CDx project pipeline by generating high-impact collateral for targeted biomarkers. 
  • Provide technical expertise in Biopharma Team interactions with potential partners. 
• Support biopharma partnering and attend partner meetings to gather biomarker requirements and communicate rules/technical details to partners 
• Manage regularly scheduled cross-functional meetings to ensure that collaborative work is completed on time as needed and that biomarker rules are correctly integrated for biomarker reporting. 
• Function as a subject matter expert on cancer biology, clinical reporting, and biomarker strategy and implementation discussions. 
• Provide key contributions to the clinical and analytical studies in the program, including but not limited to protocol development, testing and execution, and biomarker analysis. 
• Contribute to the planning and delivery of key components of regulatory submissions, including but not limited to Q-subs, PMAs, and sPMAs. 
• Provide strategic contributions in addressing issues related to biomarker analysis and biomarker harmonization. 
• Represent the Biomarker team in key regulatory meetings. 
• Mentor or supervise junior members on clinical reporting of biomarkers, study design, and project deliverables. 
• Other duties as assigned. 

Qualifications:

Basic Qualifications:

• Master’s Degree in Computational Biology, Bioinformatics, Biochemistry, Molecular Biology, Biochemistry, Genetics, Cancer Genomics and 3+ years of relevant working experience; OR, 
• Ph.D. and 1+ years relevant working experience. 

Preferred Qualifications:

• Ph.D. in Cancer Genomics, Cancer Biology, Molecular Biology, Biochemistry, or Genetics. 
• 3+ years of relevant industry experience. 
• Experience with clinical reporting and clinical trial / CDx biomarker strategy. 
• Extensive knowledge of predictive biomarkers for cancer therapy. 
• Strong scientific understanding of cancer molecular biology and genomics 
• Knowledge and experience with Next-Generation Sequencing (NGS). 
• Strong analytical skills with experience in FMI genomic data analysis using FMI databases using pre-developed scripts. 
• Ability to work well under pressure while maintaining a professional demeanor. 
• Ability to work independently in a multidisciplinary, fast-paced, dynamic, and results-oriented environment. 
• High level of attention to detail with a focus on quality. 
• Excellent teamwork, time management, and organizational skills. 
• Demonstrated record of successful independent work and contributions to team projects. 
• Understanding of HIPAA and importance of privacy of patient data. 
• Commitment to FMI values: patients, innovation, collaboration, and passion. 

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