Clinical Scientist, Clinical Development
$215,000–$230,000 year
RemoteUnited States
Job Summary
Lead study design, protocol authoring, and regulatory filings for novel antibody-based therapies in rheumatic and immune-mediated diseases. Collaborate cross-functionally with clinical operations, regulatory, and translational science teams to develop data quality plans, integrate biomarkers, and oversee site selection, monitoring, and close-out. Interpret clinical data on safety, efficacy, and PK/PD to inform decision-making, present findings to senior management and external stakeholders, and author scientific meeting materials and regulatory documentation. Monitor the competitive landscape to support strategic positioning of pipeline programs.
Required Qualifications
- PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline
- 5+ years (or more for senior levels) of clinical development experience in the biotech/pharma industry
- at least 2 years in rheumatology , or other immune-mediated disease area
- Demonstrated experience designing and executing clinical trials in rheumatology, or other I&I therapeutic area
- Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints
- Familiarity with regulatory requirements (FDA/ICH guidelines, GCP) and Good Clinical Practice
- Proven ability to work cross-functionally in a matrix organization (clinical operations, translational science, regulatory, QA)
- Excellent written and verbal communication skills
- presentation and interpersonal skills
- ability to influence diverse stakeholders
- Comfortable working in a fast-paced, dynamic environment with ambiguity
- willing to wear multiple hats
Desired Qualifications
- MSc plus significant industry experience
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