Senior Clinical Scientist, Immunology

Senior Clinical Scientist

The Senior Clinical Scientist provides scientific leadership for one or more clinical trials or key components of a clinical development program within the assigned therapeutic area. This role partners with Clinical Directors, Study Managers, Clinical Operations, Medical Monitoring, Data Management, Statistics, and Regulatory colleagues to ensure the scientific integrity, quality, and successful execution of clinical studies.

The Senior Clinical Scientist applies expertise in disease biology, clinical research, and drug development to support study design, clinical data review, interpretation of results, and generation of scientific insights that inform development decisions and advance protocol objectives.

Job Responsibilities:

Clinical Development & Scientific Leadership

• Serve as the lead Clinical Scientist for assigned clinical trial(s), providing scientific oversight from study planning through analysis and reporting.
• Contribute to the development of clinical protocols, protocol amendments, informed consent forms, case report forms, data review plans, and other study-related documents.
• Partner with Clinical Directors and cross-functional study teams to ensure study objectives, endpoints, assessments align with development strategy.
• Maintain knowledge of evolving scientific literature, treatment guidelines, competitive developments, and emerging therapies within the therapeutic area.

Clinical Data Review & Scientific Insights

• Lead ongoing review and interpretation of clinical data to assess patient safety, protocol adherence, data quality, and study conduct.
• Collaborate with Medical Monitors and Clinical Directors to evaluate safety signals, protocol deviations, patient profiles, laboratory findings, and efficacy outcomes.
• Analyze and interpret clinical trial data to identify meaningful trends and generate scientific insights that support study deliverables
• Contribute to study reports, regulatory documents, publications, scientific presentations, and internal governance materials.

Cross-Functional Collaboration

• Collaborate closely with Clinical Operations, Data Management, Programming, Biostatistics, and Regulatory Affairs to support high-quality study execution and delivery.
• Provide scientific expertise and guidance to study teams and mentor junior clinical scientists as appropriate.
• Effectively communicate complex scientific concepts and study findings to both technical and non-technical audiences.
• Influence decisions and drive alignment within a matrix-based global organization.

Rheumatology Expectations

• Preferred candidates will possess an advanced scientific or clinical degree (PharmD, PhD, MD, DO, PA or ANRP) and experience supporting clinical development programs in Rheumatology, Immunology, Autoimmune, or Inflammatory Diseases.

Key Focus Areas

• Strong understanding of rheumatologic disease biology, pathophysiology, and treatment paradigms for immune-mediated diseases.
• Ability to interpret efficacy, safety, biomarker, and patient-reported outcome data within the context of disease-specific endpoints and evolving standards of care.
• Experience conducting medical review of clinical trial data and contributing to safety and efficacy assessments.
• Ability to translate scientific findings into actionable insights that support clinical development strategy
• Demonstrated scientific curiosity and commitment to staying current with advancements in rheumatology research, disease mechanisms, and emerging treatment approaches.

Education & Experience

Required

• Bachelor's degree with 5+ years, Master's degree with 3+ years, or equivalent experience in pharmaceutical, biotechnology, clinical research, drug development, or related medical fields.

Preferred

• Advanced degree (PharmD, PhD, MD, DO, PA or ANRP).
• Experience in Rheumatology clinical development.
• Experience with protocol development, clinical data review, medical monitoring support, and cross-functional drug development teams.

Required Skills:

Clinical Data, Clinical Research, Clinical Study Design, Clinical Trials, Ethical Standards, ICH GCP Guidelines, Immunology, Medical Monitoring, Regulatory Compliance, Risk Management

Preferred

Skills:

Clinical Development, Study Design, Study Planning

Salary Range for this role is $ - $