The candidate will guide the overall strategy and lead implementation of companion diagnostics from development through regulatory approval across Blueprint’s portfolio. Blueprint is committed to developing innovative personalized medicines and this individual will play a significant role in making this a reality for patients.
- Lead the CDx strategy and implementation for diagnostics across the Blueprint portfolio in alignment with the development teams.
- Lead the evaluation and selection of the appropriate IVD partner for each program in partnership with other functional stakeholders.
- Manage companion diagnostic development partnerships from development through approval and launch.
- Contribute to authoring of relevant portions of clinical protocols, informed consents, regulatory submissions (e.g., IND, NDA, IDE, PMA).
- Provide subject matter expertise to development programs regarding appropriate diagnostic approaches.
- Maintain awareness of emerging technologies, the competitive landscape and evolution of the global regulatory environment regarding diagnostics.
- PhD (or equivalent) in life sciences with at least 8 years of relevant experience in biomarker and diagnostic development, preferably in the oncology setting.
- Direct experience in the development of in vitro diagnostics and ideally with companion diagnostics with an understanding of the current and evolving global regulatory environment.
- Experience with existing diagnostic assay technologies (e.g., next generation sequencing, immunohistochemistry, polymerase chain reaction) as well emerging methodologies.
- A collaborator who communicates in an open, clear, complete, timely and consistent manner
- Capable of developing innovative solutions to complex problems and communicating strategy to senior management.
- Comfortable in a results-driven, highly accountable environment where you can make a clear impact