Director overseeing strategic and operational management of clinical solutions for Capital Blue Cross. Leading requirements, workflow design, and operational enablement for care management applications.
About the role
- Executive Director leading Diagnostic Development Teams in Companion Diagnostics. Overseeing strategy development and execution for CDx and digital pathology projects.
Responsibilities
- Lead cross-functional DxDT including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy, development and implementation of CDx projects – and associated DP when relevant – for a portfolio of various assets/biomarkers, mainly in the therapeutic area of Oncology
- Supervise PhD-/MD-level employees leading and executing diagnostic projects within CDx subteams and coordinating the work conducted with our external Dx partners, including associated DP efforts when needed
- Partner with internal stakeholders (e.g. clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies to address those needs
- Contribute to the selection of appropriate assays, platforms and Dx partners for the execution of biomarker strategies, including overseeing possible design/execution of pilot studies with Dx vendors
- Identify and assess novel technologies/platforms with potential for CDx application, including e.g. DP companies/platforms
- Oversee team preparation of Dx-related regulatory documents including, for example, pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs, and participation in meetings with global regulatory agencies to provide CDx expertise
- Oversee team members performing operational tasks required to execute assigned projects as needed, e.g. ordering samples, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting, etc.
- Serve as a subject matter expert within our Company, collaborating with project teams, biomarkers, clinical operations, regulatory affairs, medical affairs and commercial on the implementation of global CDx assay strategies in global clinical trials.
- Oversee internal project-level senior management and governance interactions relevant to CDx
- Oversee DxDT input into preclinical and early-stage oncology programs
- Provide CDx expertise/assessment for due diligence teams.
Requirements
- Minimum of 8 years of experience in industry setting
- Extensive experience with one or more major biomarker platforms (i.e. NGS, IHC, PCR)
- Knowledge of the discovery, development and application of biomarkers in support of decision making for drug development and as CDx
- Demonstrated track record in the development and approval of CDx
- Demonstrated expertise in diagnostic development as evident by peer review publication record, patents, and/or products
- Demonstrated experience in developing and implementing strategic approaches across functional groups and in conjunction with global pharma teams
- Demonstrated experience in working with clinical teams to support design, implementation and analysis of clinical trials incorporating molecular biomarkers in order to yield data that can support CDx development and regulatory submissions
- Experience with requirements for EU IVDR, China HGRAC, Japan PMDA, and other global markets for CDx development/registration
- Proven decision-making and planning skills
- High level of verbal and written communication skills including presentation capabilities to senior executives.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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