Sr. Principal Scientist (Senior Director), Laboratory Lead - Molecular Pathology

MSD • Rahway, NJ

7d • Hybrid

About The Position

Translational Molecular Biomarkers (TMB) develops, validates, and deploys biomarker assays across all therapeutic areas and stages of clinical development to enable pipeline decision-making. TMB laboratories translate biomarker strategies into fit-for-purpose clinical assays that inform target engagement, mechanism of action, patient selection, pharmacodynamic response, and clinical outcomes. The Molecular Pathology Laboratory Lead is a senior scientific and people leader responsible for the strategic direction and operations of the Molecular Pathology laboratory. The successful candidate will lead a team of laboratory-based scientists developing, validating, transferring, and deploying tissue-based biomarker assays in support of our Company's clinical development pipeline. The successful candidate will bring deep expertise in histology and tissue-based technologies, including immunohistochemistry, in situ hybridization, multiplex assays, and digital pathology. They will develop scientific talent and partner across our Company teams to deliver decision-enabling biomarker data for clinical programs.

Requirements

• Master’s degree, Ph.D., M.D., or international equivalent professional degree in a life sciences discipline.
• 12+ years of experience with a Master’s degree or 10+ years with a Ph.D. or M.D., including at least three years of direct people management or laboratory leadership.
• Demonstrated ability to lead laboratory operations, balance multiple priorities, allocate resources, manage timelines, and deliver high-quality results on time.
• Strong working knowledge of fit-for-purpose bioanalytical development and clinical laboratory quality systems, including GxP, CAP, and CLIA requirements where applicable.
• Proven ability to influence, collaborate, and communicate complex scientific and operational topics clearly across functions.
• Companion Diagnostics (CDx)
• Histopathology
• Laboratory Management
• Laboratory Operations
• Molecular Pathology
• People Management
• Pharmaceutical Industry
• Tissue Histology
• Translational Research

Nice To Haves

• Experience leading a histology, translational research, or clinical biomarker laboratory.
• Demonstrated scientific leadership through publications, patents, or invited presentations.
• Experience establishing new laboratory capabilities, leading laboratory transformation, or implementing operational and quality improvements.
• Experience supporting biomarker strategies and assay execution for clinical trials.
• Histotechnology certification (HT or HTL), or equivalent formal histotechnology training.
• Experience overseeing work performed in a CAP-accredited or CLIA-certified laboratory.
• Expertise in digital pathology, including the development of image-analysis algorithms or models using pathology image analysis software.

Responsibilities

• Provide strategic and operational leadership for the development, validation, and clinical deployment of tissue-based biomarker assays.
• Establish scientifically rigorous, fit-for-purpose assay strategies aligned with the biomarker question, stage of development, and intended use.
• Advise on tissue acquisition and handling strategies and provide technical guidance on experiment design and assay validation for early- and late-stage clinical programs.
• Evaluate and implement new technologies that expand Molecular Pathology capabilities and demonstrate value in translational biomarker development.
• Build, lead, mentor, and develop a high-performing team of scientists in an inclusive environment in which team members contribute their perspectives, challenge constructively, and deliver results together.
• Set clear roles and performance expectations aligned with portfolio priorities while fostering accountability, scientific rigor, collaboration, and innovation.
• Contribute to internal and external scientific communications, including study reports, publications, conference presentations, and capability presentations.
• Provide daily laboratory leadership, including work prioritization, capacity planning, sample and reagent readiness, data review, instrument oversight, documentation, and timely delivery of high-quality results.
• Manage laboratory resources, budgets, capital planning, and equipment lifecycles.
• Establish robust processes for assay development, validation, transfer, clinical sample testing, reagent management, and equipment maintenance.
• Ensure that laboratory activities are conducted in accordance with applicable safety requirements, standard operating procedures, quality standards, and regulatory expectations, including applicable GxP, CAP, or CLIA requirements.
• Oversee the preparation, review, and approval of assay development and analytical validation plans and reports, standard operating procedures, and laboratory records.
• Provide technical oversight of external tissue assay vendors and partner laboratories, including vendor selection and qualification, quality review, performance monitoring, issue resolution, and delivery of fit-for-purpose assay results and documentation.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior