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

About this role

Job Description

Position Overview 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.

Primary Activities

Scientific and Technical Leadership

• 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.

People Leadership

• 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.

Laboratory Operations, Quality, and Compliance

• 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.

Education Minimum Requirement

• Master’s degree, Ph.D., M.D., or international equivalent professional degree in a life sciences discipline.

Required Experience and Skills

• 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.

Preferred Experience and Skills

• 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.

Required Skills: Companion Diagnostics (CDx), Histopathology, Laboratory Management, Laboratory Operations, Molecular Pathology, People Management, Pharmaceutical Industry, Tissue Histology, Translational Research Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected ch

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