Distinguished Scientist, Companion Diagnostics
Merck
June 24, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Primary Responsibilities:
- Lead cross-functional Dx Development Team (DxDT) to drive CDx strategy, development, and implementation for oncology biomarker/asset portfolios (including associated digital pathology when relevant).
- Supervise PhD-/MD-level employees executing diagnostic projects and coordinate work with external Dx partners (including DP efforts as needed).
- Partner with internal stakeholders (clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies.
- Select appropriate assays/platforms and Dx partners; oversee pilot study design/execution with Dx vendors.
- Identify and assess novel technologies/platforms for CDx application.
- Oversee preparation of Dx-related regulatory documents (e.g., pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs) and provide CDx expertise in meetings with global regulatory agencies.
- Oversee operational execution support (e.g., sample ordering, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting).
- Serve as a subject matter expert for implementing global CDx assay strategies in global clinical trials.
- Oversee CDx-related governance with senior management; 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:
- 8+ years industry experience.
- Extensive experience with biomarker platforms (NGS, IHC, PCR).
- Knowledge of biomarker discovery/development/application for drug development and CDx.
- Track record in CDx development and approval.
- Diagnostic development expertise (publications, patents, and/or products).
- Strategic cross-functional leadership with global pharma teams.
- Experience designing/implementing/analyzing clinical trials with key biomarkers to support CDx development and regulatory submissions.
- Familiarity with EU IVDR, China HGRAC, Japan PMDA, and other global CDx markets.
- Strong decision-making, planning, and verbal/written communication to senior executives.
Preferred Experience and Skills:
- Experience in both pharma and Dx settings.
- Deep technical knowledge (e.g., ctDNA, IHC/pathology, digital pathology).
- Direct interfacing with global health authorities.
Required/Preferred Skills:
- Analytical thinking, assay/bioanalytical techniques, biomarker development, clinical trials, communication, leadership, strategic foresight.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Apply no later than the day before the posting end date (07/1/2026). Requisition ID: R400608.
- Lead cross-functional Dx Development Team (DxDT) to drive CDx strategy, development, and implementation for oncology biomarker/asset portfolios (including associated digital pathology when relevant).
- Supervise PhD-/MD-level employees executing diagnostic projects and coordinate work with external Dx partners (including DP efforts as needed).
- Partner with internal stakeholders (clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies.
- Select appropriate assays/platforms and Dx partners; oversee pilot study design/execution with Dx vendors.
- Identify and assess novel technologies/platforms for CDx application.
- Oversee preparation of Dx-related regulatory documents (e.g., pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs) and provide CDx expertise in meetings with global regulatory agencies.
- Oversee operational execution support (e.g., sample ordering, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting).
- Serve as a subject matter expert for implementing global CDx assay strategies in global clinical trials.
- Oversee CDx-related governance with senior management; 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:
- 8+ years industry experience.
- Extensive experience with biomarker platforms (NGS, IHC, PCR).
- Knowledge of biomarker discovery/development/application for drug development and CDx.
- Track record in CDx development and approval.
- Diagnostic development expertise (publications, patents, and/or products).
- Strategic cross-functional leadership with global pharma teams.
- Experience designing/implementing/analyzing clinical trials with key biomarkers to support CDx development and regulatory submissions.
- Familiarity with EU IVDR, China HGRAC, Japan PMDA, and other global CDx markets.
- Strong decision-making, planning, and verbal/written communication to senior executives.
Preferred Experience and Skills:
- Experience in both pharma and Dx settings.
- Deep technical knowledge (e.g., ctDNA, IHC/pathology, digital pathology).
- Direct interfacing with global health authorities.
Required/Preferred Skills:
- Analytical thinking, assay/bioanalytical techniques, biomarker development, clinical trials, communication, leadership, strategic foresight.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Apply no later than the day before the posting end date (07/1/2026). Requisition ID: R400608.