Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Translational Discovery & Development Biomarkers
Job Category:Scientific/Technology
All Job Posting Locations:Cambridge, Massachusetts, United States of America, Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a Principal Scientist, Translational Science Program Lead - Immunology, for Immunology programs spanning discovery through clinical development. This role is located onsite in either Cambridge, MA or Spring House, PA.
The TSPL will be the scientific and strategic owner of the end-to-end translational strategy for assigned assets, translating therapeutic mechanism and human disease biology into decision-linked evidence plans that guide portfolio entry, dose and regimen selection, proof of biology, patient stratification, clinical development, and regulatory strategy.
The successful candidate will lead through scientific credibility and influence in a highly matrixed environment. They will anticipate upcoming program decisions, integrate expertise across functions, and mobilize teams toward clear recommendations and execution. This role requires deep immunology expertise, strong translational judgment, proficiency with multidimensional biomarker data, and the ability to communicate complex evidence, uncertainty, trade-offs, and recommendations to project teams and governance bodies.
- Own the translational strategy: Develop and maintain integrated, stage-appropriate translational plans that connect disease biology, therapeutic mechanism, pharmacology, biomarkers, clinical endpoints, and key program decisions.
- Anticipate evidence needs: Work one or more inflection points ahead to define critical questions, evidence requirements, decision criteria, timelines, dependencies, risks, and mitigation options.
- Lead precision medicine strategy: Develop testable hypotheses for disease segmentation, patient stratification or selection, response and non-response, and clinically meaningful biomarker endpoints; integrate these hypotheses into target product profiles, study designs, and stage-gate decisions.
- Translate science into clinical plans: Define biomarker strategies addressing target engagement, pharmacodynamic activity, proof of biology, dose and regimen selection, disease heterogeneity, efficacy, safety, and differentiation.
- Lead in the matrix: Represent Translational Science on discovery and clinical development teams and align Discovery, Clinical Development, Translational Medicine, Clinical Pharmacology, Data Science, Biostatistics, Diagnostics, Regulatory, Clinical Operations, Commercial, and other partners around an integrated recommendation.
- Ensure execution readiness: Partner with study leads, laboratory scientists, operations teams, and vendors to translate strategy into fit-for-purpose assays, sampling plans, analysis plans, data-delivery timelines, budgets, and contingency plans.
- Interpret integrated evidence: Lead the analysis and interpretation of preclinical, clinical, and high-dimensional datasets, including transcriptomic, genomic, proteomic, cellular, tissue, and other multimodal data, to generate actionable biological and clinical insights.
- Drive decisions and manage risk: Communicate what is known, what remains uncertain, why it matters, and what action is recommended. Surface risks early with options, trade-offs, mitigation plans, and a preferred path.
- Strengthen the portfolio: Use human data and biospecimens to support target validation, indication prioritization, back-translation, lifecycle strategy, and reuse of evidence, assays, and learnings across assets.
- Lead external innovation: Establish and direct collaborations with academic investigators, consortia, contract research organizations, technology providers, and external experts to close defined strategic or capability gaps.
- Support regulatory and scientific communication: Author or provide strategic input to translational plans, protocols, analysis plans, investigator's brochures, INDs and other regulatory submissions, clinical study reports, abstracts, manuscripts, and governance presentations.
- Build organizational capability: Mentor scientists and study leads, model rigorous and inclusive scientific leadership, contribute to functional strategy and standards, and identify emerging technologies-including responsible applications of AI and advanced analytics-that improve decision quality and portfolio execution.
What Success Looks Like- Translational plans are explicitly linked to asset decisions and arrive early enough to influence them.
- Biomarker strategies are focused, feasible, scalable, and supported by clear hypotheses, contexts of use, and analysis plans.
- Cross-functional teams understand the integrated evidence, key uncertainties, trade-offs, and recommended path.
- Assays, samples, data, vendors, budgets, and regulatory documentation are ready for critical program milestones.
- Precision-medicine and back-translation opportunities are incorporated from the outset rather than added after study design.
- Scientific standards, capabilities, and learnings are shared across the Immunology portfolio.
Required Qualifications- PhD or MD/PhD in immunology, translational medicine, molecular or cellular biology, pharmacology, or a related scientific discipline.
- At least 5 years of relevant post-degree experience, with substantial experience in the pharmaceutical or biotechnology industry strongly preferred.
- Demonstrated experience developing and executing translational or clinical biomarker strategies for drug discovery or development programs.
- Strong knowledge of immunology and immune-mediated disease biology, with the ability to connect mechanism of action to measurable human biology and clinical outcomes.
- Experience with biomarker applications such as target engagement, pharmacodynamics, proof of biology, patient stratification or selection, disease activity, dose selection, and treatment-response assessment.
- Demonstrated success leading cross-functional initiatives and influencing decisions without direct authority in a matrixed environment.
- Experience interpreting complex translational datasets and partnering with quantitative scientists to develop rigorous, decision-relevant analyses.
- Understanding of fit-for-purpose assay development, validation, clinical implementation, sample and data flows, and work with external laboratories or research partners.
- Strong written and verbal communication skills, including the ability to tailor scientific narratives for technical teams, senior leaders, and governance audiences.
- Ability to prioritize across multiple programs, operate effectively amid ambiguity, and deliver high-quality work against demanding timelines.
Preferred Qualifications- Expertise in rheumatology, autoantibody-mediated disease, B-cell or plasma-cell biology, immune reset, or another area relevant to the Immunology portfolio.
- Experience supporting programs from late discovery or candidate selection through early clinical development and into late-stage development.
- Experience integrating tissue, peripheral blood, single-cell, flow cytometry, transcriptomic, proteomic, or other multimodal data.
- Experience with precision-medicine, diagnostic, or companion-diagnostic strategies and associated regulatory considerations.
- Experience contributing to regulatory interactions or authoring translational content for regulatory submissions and clinical study reports.
- A record of scientific impact through publications, presentations, patents, external partnerships, or implementation of innovative technologies.
- Experience mentoring scientists or leading matrixed translational teams.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation -120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
- Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
The anticipated base pay range for this position is: $117,000 - $195,125
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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Required Skills:Preferred Skills:Biomarkers, Clinical Trials Operations, Coaching, Critical Thinking, Drug Discovery Development, Industry Analysis, Interdisciplinary Work, Medical Compliance, Medical Technology, Organizational Project Management, Organizing, Program Management, Quality Standards, Safety-Oriented, Scientific Research, Technologically Savvy, Translational Medicine
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
