Director, Clinical Scientist
New
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Spyre TherapeuticsBiotechnology
US- RemoteFull-TimeDirector
Salary$215,000 to $230,000
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Job Details
- Experience
- 5+ years
- Required Skills
- GCP
Requirements
- PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, or immunology preferred; alternatively, MSc with significant industry experience.
- 5+ years of clinical development experience in the biotech/pharma industry.
- At least 2 years of experience in rheumatology or other immune-mediated disease areas.
- Demonstrated experience designing and executing clinical trials.
- Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification, and immunologic endpoints.
- Familiarity with regulatory requirements including FDA, ICH guidelines, and GCP.
- Proven ability to work cross-functionally in a matrix organization.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to influence diverse stakeholders.
Responsibilities
- Lead or contribute to study design and amendments with internal and external stakeholders.
- Author and submit clinical protocols, amendments, regulatory filings, and other documentation.
- Implement data quality plans and lead medical data review and safety trend analysis.
- Integrate mechanistic biomarkers, PK/PD modelling, and patient stratification into study designs.
- Provide scientific oversight for trial execution including site selection, start-up, and monitoring.
- Interpret and present clinical data (safety, efficacy, biomarker, PK/PD) to senior management and at scientific meetings.
- Write and review scientific abstracts, posters, and study reports.
- Collaborate with regulatory affairs to ensure adherence to FDA/ICH and GCP standards.
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