The Senior Director, Companion Diagnostics within Precision Medicine, heads CDx development at AbbVie, developing strategies for CDx assay development, clinical validation, regulatory approval, and commercial launch, working closely with a Diagnostic Commercial partner. The incumbent is expected to create a framework for interactions and alignment across key stakeholders within Precision medicine and Development but also cross-functionally with Medical Affairs, Regulatory and Commercial organizations. The incumbent is expected to lead a team of Director level reports, each of which responsible for strategies at a program level. Finally, a key success criterion is advancing uptake of Abbvie’s CDx enabled marketed products through creative lifecycle development of diagnostic assays and panels, aligned with Commercial, Access and Medical Affairs colleagues. This complexity will require development of an overarching CDX strategy and framework to guide the organization commensurate with the growing and evolving pipeline of CDx enabled clinical candidates.
- Lead the Precision Medicine CDx Development Group with direct reports responsible for CDx Strategy for individual projects.
- Manage a team of highly proficient CDx Development Leaders, ensuring high quality technical, scientific, and strategic decision making.
- Develop and coordinate the overarching CDx strategy across projects for CDx and Complementary Diagnostics as needed.
- Represent CDx Development strategy, budget requests to Governance and Senior Management to ensure that key milestones are met with organization support and resourcing.
- Work closely with the Commercial, Regulatory and Go To Market teams to coordinate development and launch of CDx assay for Oncology and other therapeutic areas.
- Direct the development, outsourcing and validation of clinically applicable companion diagnostic assays Design, implement and oversee biomarker and diagnostic testing and data analysis.
- Provide expertise to development project teams to ensure access to state-of-the-art thinking on appropriate biomarker and diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarkers and companion diagnostics.
- Highly experienced biomedical leader (PhD, MD, or MD/PhD) with a minimum of 15 years of industry experience with expertise in a pharmaceutical development organization, developing biomarkers; Preferably significant experience within a commercial diagnostic organization focused on companion diagnostic development in collaboration with Pharma partners.
- Familiarity with Design Control and regulatory requirements for Diagnostic Development and clinical validation.
- Demonstrated excellence in building, developing and managing high-performing CDx scientists
- Demonstrated excellence in developing and implementing overarching therapeutic area biomarker and/or CDx strategies
- Demonstrated excellence in independently leading and conducting research and ability to evaluate, interpret and present complex scientific data
- In depth experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and companion diagnostics.
- Experience in human translational research with biomarker application in clinical trials and awareness of the challenges of implementing biomarker and diagnostic technologies in the clinical setting
- Excellent leadership skills including motivation and delegation
- Excellent verbal and written communication and presentation skills in English
- High level of initiative and ability to work independently
- High level of business awareness
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