Senior Principal Scientist/Senior Director Companion Diagnostics

Job Description

In this Senior Principal Scientist/Senior Director position in the Companion Diagnostic (CDx) Development Group, this team member will provide strategic leadership for CDx development and commercialization for a variety of programs, and oversee execution of those strategies in collaboration with the cross-functional CDx Teams, the Early Development Teams (EDTs), Asset Development Teams (ADTs), Product Development Teams (PDTs) and our diagnostic partners. Position reports to Executive Director, CDx Development.

 

Primary Responsibilities:

• Develop and direct CDx/IVD strategic approaches and lead CDx development projects spanning from preclinical through Phase 1-3 clinical trials and registration/launch

• Lead cross-functional CDx Teams for various assets/biomarkers including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy development and implementation of CDx projects

• Partner with internal stakeholders (e.g. ADTs, PDTs, EDTs, Biomarker Leads, CDx Regulatory, Commercial) to assess program needs and develop CDx strategies to address those needs

• Drive CDx partner/platform assessment and selection and provide leadership in Joint Project Teams with CDx partners to oversee execution

• Lead internal governance interactions relevant to CDx

• Serve as a subject matter expert within our Company, collaborating with ADTs, PDTs, EDTs, biomarker leads, clinical operations, and regulatory affairs on the implementation of CDx assay strategies in clinical trials

• Responsible in conjunction with CDx Regulatory and other functions for CDx content for relevant regulatory documents including, for example, pre-submissions, briefing books, IDEs, PMAs

• Participate in meetings with global regulatory agencies to provide CDx expertise

• Provide CDx input into preclinical and early-stage oncology programs

• Oversee transfer of assays from in-house efforts to Dx companies

• Provide CDx expertise/assessment for due diligence teams

• Evaluate relevant new technologies including possible design/execution of pilot studies with Dx vendors

Education Minimum Requirements: 

• PhD, MD or MD/PhD

Required Experience and Skills:

• Minimum of 7 years of experience in industry or academic setting

• Knowledge of the discovery, development and application of molecular and/or IHC biomarkers/assays in support of decision making for drug development and as CDx

• Demonstrated expertise in molecular diagnostic/CDx development as evidenced by peer review publication record, patents, and/or products

• Demonstrated experience in developing and implementing strategic approaches across diverse 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

• High level of verbal and written communication skills including presentation capabilities

Preferred Experience and Skills:

• Ten or more years' experience in industry, preferably in both pharma and Dx settings

• 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 focus such as circulating tumor DNA (ctDNA), immunohistochemistry / pathology, digital pathology

• Experience in development of digital pathology algorithms/assays

Required Skills:

Companion Diagnostics (CDx), Cross-Functional Teamwork, Diagnostics Development, Immunohistochemistry (IHC), Professional Networking, Strategic Leadership

Preferred Skills:

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