Merck · 17 hours ago
Executive Director, Companion Diagnostics
Rahway, NJ
Full-time
Hybrid
Director/Executive
$210K/yr - $331K/yr
8+ years expMerck is a leading company in the pharmaceutical industry, seeking an Executive Director for Companion Diagnostics. The role involves leading a team in the development and execution of diagnostic strategies, overseeing projects related to biomarkers, and collaborating with various stakeholders to advance oncology-related initiatives.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
PhD
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
Analytical Thinking
Assay
Bioanalytical Techniques
Biomarker Development
Clinical Trials
Communication
Companion Diagnostics (CDx)
Data Analysis
Drug Development
Innovation
Leadership
Scientific Leadership
Strategic Foresight
Preferred
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
Benefits
Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-02-06
2026-02-05
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