Principal Scientist, Companion Diagnostics, Translational Oncology Full-time

Principal Scientist/Director Position in Translational Oncology

In this Principal Scientist/Director position within Translational Oncology, this team member will provide leadership for aligned and integrated development and commercialization strategies for diagnostics (Dx)/companion diagnostics (CDx), including associated digital pathology (DP) projects when applicable, and execution of those strategies in collaboration with Product Development Teams (PDTs), Asset Development Teams (ADTs) and our diagnostic partners. Position reports to Executive Director, CDx.

Primary Responsibilities:

• Direct CDx/IVD development projects, including associated DP efforts when needed, within Translational Oncology
• Lead cross-functional CDx (and where relevant, DP) development teams for various assets/biomarkers (including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, Alliance Management, etc.) to drive the implementation of Dx projects and coordinate the work conducted with our external Dx partners.
• Interface directly with scientists and physicians in discovery sciences, early-stage clinical development, and late-stage clinical development, as well as other PDT & ADT members, to craft the project team's CDx (and associated DP if relevant) development strategy.
• Lead the selection of appropriate assays and Dx platforms for the execution of biomarker strategies.
• Lead digital pathology efforts as needed for each individual CDx project
• Serve as a subject matter expert within our Company, collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global CDx assay strategies in global clinical trials.
• Participate in preparation of Dx-related regulatory documents including, for example, pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs.
• Participate in meetings with global regulatory agencies to provide CDx expertise.
• Provide CDx input into early-stage oncology programs.
• Assist in the transfer of assays from in-house efforts to in vitro Dx companies.
• Provide CDx expertise/assessment for due diligence teams.
• Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors.
• Perform 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.

Education Minimum Requirements:

• MD/PhD, MD or PhD

Required Experience and Skills:

• Minimum of 7+ years of experience in industry or academic setting, preferably in both pharma and Dx settings
• Extensive experience with one or more major molecular biomarker platforms (i.e. NGS, IHC, PCR)
• Knowledge of the discovery, development and application of molecular biomarkers in support of decision making for drug development and as CDx
• Demonstrated track record in the development of CDx
• Demonstrated expertise in molecular diagnostic development as evident by peer review publication record, patents, and/or products
• Experience influencing without direct authority, navigating complex or matrix organizations and successfully networking and forming partnerships with cross-functional teams.
• Proven decision-making and planning skills
• High level of verbal and written communication skills including presentation capabilities to senior executives

Preferred Experience and Skills:

• Experience in development of digital pathology algorithms/assays
• Experience with requirements for EU IVDR, China HGRAC, JPMA, and other global markets for CDx development/registration
• Experience directly interfacing in meetings and written documents with global health authorities
• Deep technical knowledge in an area of interest such as circulating tumor DNA (ctDNA), immunohistochemistry / pathology, digital pathology

Required Skills:

Biomarker Assay Development, Clinical Development, Clinical Judgment, Clinical Medicine, Companion Diagnostics (CDx), Cross-Departmental Collaboration, Data Analysis, Diagnostics, Diagnostics Development, Drug Development, IVD, Mentoring Staff, Molecular Diagnostics, Project Reviews, Regulatory Affairs Compliance, Regulatory Experience, Research Proposal Development, Scientific Writing, Translational Oncology

Preferred Skills:

Digital Pathology, Global Regulatory