Senior Principal Scientist, Translational Clinical Biomarkers
Merck
12 days ago
Remote friendly (Upper Gwynedd, PA)
United States
Clinical Research and Development
Primary Responsibilities
- Lead and shape integrated immunology biomarker strategies across discovery and early-/late-stage clinical programs; ensure clear hypotheses, fit-for-purpose endpoints, and explicit linkage to key development decisions.
- Serve as biomarker strategy lead in cross-functional program teams and represent teams in governance forums; address mission-critical questions for forward and reverse translation.
- Advance biomarker-driven insights to inform target validation, patient selection, and go/no-go decisions.
- Translate disease biology and mechanism of action into clinically actionable biomarker strategies (e.g., proof of biology, pharmacodynamic effects, precision medicine, surrogate efficacy endpoints).
- Select and apply innovative biomarker approaches aligned with biological rationale and clinical utility.
Cross-functional Leadership & Alignment
- Lead biomarker sub-teams and working groups (clinical, discovery, translational, regulatory, biostatistics, and data sciences).
- Provide hypothesis-driven, decision-focused scientific leadership.
- Grow and develop team members through mentorship.
Data Interpretation & Communication
- Champion biomarker analysis plans; interpret complex datasets and deliver rigorous, clinically meaningful conclusions.
- Communicate insights to internal stakeholders, governance bodies, and external scientific audiences.
- Support external engagement (publications, presentations, KOL interactions).
Qualifications
- Ph.D. or M.D. with 12+ years in immunology (or related field) with experience in autoimmune diseases and/or translational medicine.
Required Skills/Experience
- Deep immunology expertise in immune-mediated/inflammatory diseases (GI/mucosal inflammation, rheumatology, or dermatology).
- Proven translational track record informing clinical development decisions; strong collaboration in matrixed environments.
- Analytical/problem-solving skills; communicate to senior leadership and external stakeholders.
- Working knowledge of biostatistics, bioinformatics, and advanced analytics.
- Strategic, leadership presence, ability to influence cross-functional/senior stakeholders.
Preferred Skills
- Experience advancing precision medicine strategies; direct managerial experience.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Requisition ID: R399013.
- Lead and shape integrated immunology biomarker strategies across discovery and early-/late-stage clinical programs; ensure clear hypotheses, fit-for-purpose endpoints, and explicit linkage to key development decisions.
- Serve as biomarker strategy lead in cross-functional program teams and represent teams in governance forums; address mission-critical questions for forward and reverse translation.
- Advance biomarker-driven insights to inform target validation, patient selection, and go/no-go decisions.
- Translate disease biology and mechanism of action into clinically actionable biomarker strategies (e.g., proof of biology, pharmacodynamic effects, precision medicine, surrogate efficacy endpoints).
- Select and apply innovative biomarker approaches aligned with biological rationale and clinical utility.
Cross-functional Leadership & Alignment
- Lead biomarker sub-teams and working groups (clinical, discovery, translational, regulatory, biostatistics, and data sciences).
- Provide hypothesis-driven, decision-focused scientific leadership.
- Grow and develop team members through mentorship.
Data Interpretation & Communication
- Champion biomarker analysis plans; interpret complex datasets and deliver rigorous, clinically meaningful conclusions.
- Communicate insights to internal stakeholders, governance bodies, and external scientific audiences.
- Support external engagement (publications, presentations, KOL interactions).
Qualifications
- Ph.D. or M.D. with 12+ years in immunology (or related field) with experience in autoimmune diseases and/or translational medicine.
Required Skills/Experience
- Deep immunology expertise in immune-mediated/inflammatory diseases (GI/mucosal inflammation, rheumatology, or dermatology).
- Proven translational track record informing clinical development decisions; strong collaboration in matrixed environments.
- Analytical/problem-solving skills; communicate to senior leadership and external stakeholders.
- Working knowledge of biostatistics, bioinformatics, and advanced analytics.
- Strategic, leadership presence, ability to influence cross-functional/senior stakeholders.
Preferred Skills
- Experience advancing precision medicine strategies; direct managerial experience.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Requisition ID: R399013.