Principal Scientist - Clinical Research, Immunology Biomarker Lead

Job Description

We are seeking an accomplished and highly motivated Principal Scientist (Director) to serve as an Immunology Biomarker Lead within Translational Clinical Biomarkers. This role provides strategic and scientific leadership in the design, execution, analysis, and communication of clinical biomarker strategies in support of the immunology clinical development portfolio.

The successful candidate will drive decision-centric biomarker strategies that connect drug mechanism, disease biology, precision medicine, pharmacodynamics, dose decisions, and clinical endpoints, directly informing program- and portfolio-level decisions across the development lifecycle.

This role requires deep scientific expertise, structured decision-making, sophisticated data analysis & interpretation; and cross-functional collaboration, aligning diverse stakeholders in a fast-paced, matrixed environment.

Primary Responsibilities:

Strategic Leadership & Program Impact

- Lead and shape integrated biomarker strategies across discovery, early- and late-stage clinical programs, ensuring clear hypotheses, fit-for-purpose endpoints, and explicit linkage to key development decisions, in close collaboration with cross-functional leaders, particularly in Discovery, Late Stage Clinical Development and across Translational Medicine.

- Serve as the biomarker strategy lead within cross-functional program teams and represent multi-disciplinary team(s) in governance forums, ensuring biomarker strategies to address mission-critical questions for both forward and reverse translation.

- Inform portfolio strategy by advancing biomarker-driven insights that inform target validation, patient selection, and go/no-go decisions.

- Translate disease biology and therapeutic mechanism of action into clinically actionable biomarker strategies addressing critical program questions, e.g. proof of biology, pharmacodynamic effects, precision medicine and surrogate endpoints for efficacy.
- Drive selection and application of innovative biomarker approaches, aligned with biological rationale and clinical utility.

Cross-functional Leadership & Alignment

- Lead biomarker sub-teams and related working groups, including clinical, discovery, translational, regulatory, bio-stats, and data sciences.
- Collaborate effectively across disciplines to integrate diverse scientific perspectives into cohesive strategies.
- Provide scientific leadership to enable hypothesis-driven, decision-focused biomarker strategies.

Data Interpretation & Communication

- Champion biomarker analysis plans and provide critical scientific input to the interpretation of complex datasets to deliver scientifically rigorous and clinically meaningful conclusions.
- Clearly articulate insights to internal stakeholders, governance bodies, and external scientific audiences.
- Support external engagement, including publications, presentations, and KOL interactions, as appropriate.

Position Qualifications

Required Experience and Skills

- PhD or MD in Immunology, Biology, or related STEM degree with 7+ years experience in Immunology; MS and 10+ years of experience, or BS and 14+ years of experience. Autoimmune Diseases R&D and/or experience in translational medicine strongly preferred.
- Deep expertise in immunology and immune - mediated/inflammatory diseases, with experience in at least one of the following: Rheumatology.
- Gastrointestinal/mucosal inflammation.
- Dermatology.

- Proven track record of driving translational strategies that inform clinical development decisions, including close cross-functional collaboration and partnership.
- Demonstrated ability to lead highly matrixed teams.
- Strong analytical and problem-solving capabilities, with the ability to translate complex data into clear, decision-oriented insights.
- Excellent communication skills.

- Working knowledge with biostatistics, bioinformatics, and advanced data analytics.
- Experience advancing precision medicine strategies.

Key Success Factors

- Strategic mindset with a focus on decision impact rather than data generation alone.
- Strong leadership presence and ability to influence cross-functional stakeholders.
- Proven ability to operate effectively in a fast-moving, matrixed environment.

#EligibleforERP

Required Skills:
Biomarker Development, Biomarker Discovery, Biomarker Identification, Biomarker Qualification, Biomarkers, Clinical Development, Clinical Research, Dermatology, Gastroenterology, Gastrointestinal Disease, Immunogenicity, Immunology Research, Immuno-Oncology, Inflammatory Diseases, Omics, Personalized Medicine, Pharmacodynamics, Protocol Development, Rheumatology, Translational Medicine

Preferred Skills:

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US and Puerto Rico Residents Only:

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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 characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is
$190,800.00 - $300,300.00

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:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
11/6/2026
*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.