Executive Director, Companion Diagnostics

Job Description

The Distinguished Scientist/Executive Director within Companion Diagnostics (CDx) Development will lead one of our companys Diagnostic Development Teams (DxDTs) supervising PhD-/MD-level employees developing and overseeing CDx strategy development alignment and execution for specific projects including associated digital pathology (DP) projects when applicable. Position reports to Associate Vice President Companion Diagnostics (CDx).

Primary 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

Education Minimum Requirements:

• PhD

Required Experience and Skills:

• 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

Preferred Experience and Skills:

• Experience in both pharma and Dx settings

• Deep technical knowledge in an area of focus such as circulating tumor DNA (ctDNA) immunohistochemistry / pathology digital pathology

• Experience directly interfacing in meetings and written documents with global health authorities

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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