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.

The salary range for this role is
$173,200.00 - $272,600.00

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 employee's 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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
09/17/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.