This role provides strategic and scientific leadership for clinical biomarker strategies across an immune-mediated therapeutic portfolio from discovery to pivotal clinical studies. The position focuses on connecting disease biology, drug mechanism, precision medicine, pharmacodynamics, dose decisions, and clinical endpoints to inform development and portfolio-level decisions.
Key Responsibilities
- • 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
- • Lead biomarker sub-teams and related working groups, including clinical, discovery, translational, regulatory, bio-stats, and data sciences
- • Collaborate effectively across disciplines to integrate scientific perspectives into cohesive strategies
- • Provide scientific leadership to enable hypothesis-driven, decision-focused biomarker strategies
- • Grow and develop team members, including mentorship of direct report(s) and other scientists in the department, acting as a role model and culture driver
- • 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
Required
- • Ph.D. or M.D. with 12+ years in Immunology or related scientific discipline and relevant experience with autoimmune diseases and/or translational medicine
- • Deep expertise in immunology and immune-mediated/inflammatory diseases, with experience in at least one of the following: Gastrointestinal/mucosal inflammation, Rheumatology, 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 organizations
- • Strong analytical and problem-solving capabilities, with the ability to translate complex data into clear, decision-oriented insights
- • Excellent communication skills, including experience presenting to senior leadership and external stakeholders
- • Working knowledge with biostatistics, bioinformatics, and advanced data analytics
- • Strategic mindset with a focus on decision impact rather than data generation alone
- • Strong leadership presence and ability to influence cross-functional and senior stakeholders
- • Proven ability to operate effectively in a fast-moving, matrixed environment
Preferred
- • Experience advancing precision medicine strategies
- • Direct managerial experience
Benefits & Perks
- • Eligible for annual bonus and long-term incentive, if applicable
- • A comprehensive package of 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
We are seeking an accomplished and highly motivated Senior Principal Scientist (Sr. Director equivalent) 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 across our immune-mediated therapeutic portfolio from discovery to pivotal clinical studies.
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 strong leadership of multi-disciplinary team efforts through deep scientific expertise, structured decision-making, sophisticated data analysis & interpretation; and cross-functional collaboration, aligning 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
- Lead biomarker sub-teams and related working groups, including clinical, discovery, translational, regulatory, bio-stats, and data sciences
- Collaborate effectively across disciplines to integrate scientific perspectives into cohesive strategies
- Provide scientific leadership to enable hypothesis-driven, decision-focused biomarker strategies
- Grow and develop team members, including mentorship of direct report(s) and other scientists in the department, acting as a role model and culture driver
- 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
Education
QUALIFICATIONS:
- Ph.D. or M.D. with 12+ years in Immunology or related scientific discipline and relevant experience with autoimmune diseases and/or translational medicine
- Deep expertise in immunology and immune-mediated/inflammatory diseases, with experience in at least one of the following:
- Gastrointestinal/mucosal inflammation
- Rheumatology
- 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 organizations
- Strong analytical and problem-solving capabilities, with the ability to translate complex data into clear, decision-oriented insights
- Excellent communication skills, including experience presenting to senior leadership and external stakeholders
- Working knowledge with biostatistics, bioinformatics, and advanced data analytics
- Strategic mindset with a focus on decision impact rather than data generation alone
- Strong leadership presence and ability to influence cross-functional and senior stakeholders
- Proven ability to operate effectively in a fast-moving, matrixed environment
- Experience advancing precision medicine strategies
- Direct managerial experience
Required Skills
Autoimmune Diseases, Biomarker Research, Dermatology, Gastrointestinal Disease, Immunology, Inflammatory Diseases, Leadership, Rheumatology, Strategic Planning, Translational Medicine
Preferred Skills
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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.
Requirements
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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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The salary range for this role is
$210,400.00 - $331,100.00
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/International
VISA Sponsorship
Yes
Travel Requirements
10%
Flexible Work Arrangements
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
N/A
Job Posting End Date
06/30/2026
- 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.
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