Job Description
The Senior Clinical Scientist provides scientific leadership for one clinical trial 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.
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, 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
Key Focus Areas
- Strong understanding of autoimmune diseases including 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 immunology research, disease mechanisms, and emerging treatment approaches
Education & Experience
Required
- Advanced degree (PharmD, PhD, MD, DO, PA or ANRP) -OR-
- Bachelor's Degree in life sciences and 5+ years of experience in clinical sciences -OR-
- Master's Degree in life sciences and 3+ years of experience in clinical sciences
- Experienced with:
- Protocol development
- Clinical data review
- Medical monitoring support
- Cross-functional drug development teams
Preferred
- Experience in Immunology clinical development
clinicaltrialjobs
Required Skills:
Adaptability, Clinical Data, Clinical Operations, Clinical Research, Clinical Trials, Data Analysis, ICH GCP Guidelines, Protocol Development, Regulatory Compliance, Stakeholder Alignment, Strategic Thinking, Study Design
Preferred Skills:
Leadership, Mentorship, Technical Knowledge
Current Employees apply
Current Contingent Workers apply
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
09/29/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
