Senior Principal Scientist, Translational Clinical Biomarkers
Merck
12 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Primary Responsibilities
- Lead and shape integrated immunology biomarker strategies across discovery and early/late clinical programs, ensuring clear hypotheses, fit-for-purpose endpoints, and linkage to key development decisions.
- Serve as biomarker strategy lead in cross-functional program teams and represent teams in governance forums; address forward and reverse translation questions.
- Advance biomarker-driven insights to inform target validation, patient selection, and go/no-go decisions.
- Translate disease biology and MoA into clinically actionable biomarker strategies (e.g., proof of biology, pharmacodynamics, precision medicine, surrogate efficacy endpoints).
- Select and apply innovative biomarker approaches aligned to biological rationale and clinical utility.
- Lead biomarker sub-teams/working groups (clinical, discovery, translational, regulatory, bio-stats, data sciences); collaborate to integrate perspectives.
- Champion biomarker analysis plans; interpret complex datasets and communicate insights to internal/external audiences; support publications/presentations/KOLs.
Qualifications
- Ph.D. or M.D. with 12+ years in Immunology or related discipline; relevant experience with autoimmune diseases and/or translational medicine.
- Deep immunology expertise and experience with at least one: GI/mucosal inflammation, rheumatology, dermatology.
Required Skills/Experience
- Translational strategy experience informing clinical development decisions; lead highly matrixed organizations.
- Strong analytical/problem-solving; decision-oriented interpretation of complex data.
- Excellent communication to senior leadership/external stakeholders.
- Working knowledge of biostatistics, bioinformatics, advanced data analytics; strategic, influential leadership in fast-paced matrixed environments.
Preferred Skills
- Precision medicine strategy experience; direct managerial experience.
Benefits (if applicable)
- Eligible for annual bonus and long-term incentive.
- Comprehensive benefits: medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.
Locations
- Rahway, NJ; Boston/Cambridge, MA; or Upper Gwynedd, PA (based on preference).
- Lead and shape integrated immunology biomarker strategies across discovery and early/late clinical programs, ensuring clear hypotheses, fit-for-purpose endpoints, and linkage to key development decisions.
- Serve as biomarker strategy lead in cross-functional program teams and represent teams in governance forums; address forward and reverse translation questions.
- Advance biomarker-driven insights to inform target validation, patient selection, and go/no-go decisions.
- Translate disease biology and MoA into clinically actionable biomarker strategies (e.g., proof of biology, pharmacodynamics, precision medicine, surrogate efficacy endpoints).
- Select and apply innovative biomarker approaches aligned to biological rationale and clinical utility.
- Lead biomarker sub-teams/working groups (clinical, discovery, translational, regulatory, bio-stats, data sciences); collaborate to integrate perspectives.
- Champion biomarker analysis plans; interpret complex datasets and communicate insights to internal/external audiences; support publications/presentations/KOLs.
Qualifications
- Ph.D. or M.D. with 12+ years in Immunology or related discipline; relevant experience with autoimmune diseases and/or translational medicine.
- Deep immunology expertise and experience with at least one: GI/mucosal inflammation, rheumatology, dermatology.
Required Skills/Experience
- Translational strategy experience informing clinical development decisions; lead highly matrixed organizations.
- Strong analytical/problem-solving; decision-oriented interpretation of complex data.
- Excellent communication to senior leadership/external stakeholders.
- Working knowledge of biostatistics, bioinformatics, advanced data analytics; strategic, influential leadership in fast-paced matrixed environments.
Preferred Skills
- Precision medicine strategy experience; direct managerial experience.
Benefits (if applicable)
- Eligible for annual bonus and long-term incentive.
- Comprehensive benefits: medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.
Locations
- Rahway, NJ; Boston/Cambridge, MA; or Upper Gwynedd, PA (based on preference).