Spyre Therapeutics · 1 month ago
Director, Clinical Scientist
United States
Full-time
Remote
Lead/Staff, Director/Executive
$215K/yr - $230K/yr
5+ years expSpyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations for inflammatory bowel disease and rheumatic diseases. As a Director, Clinical Scientist, you will design, execute, and interpret clinical trials, collaborating across functions to ensure high-quality data generation and efficient program progression.
BiotechnologyTherapeutics
Responsibilities
Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders
Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs
Work closely with translational science to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints
Provide scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out
Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally and externally (investigators, scientific meetings, publications)
Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders
Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions
Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.)
Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre’s pipeline programs
Additional duties as assigned
Qualification
Required
Demonstrated experience designing and executing clinical trials IBD 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, and willing to wear multiple hats
Preferred
PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred; alternatively, MSc plus significant industry experience
5+ years of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area
Benefits
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Company
Spyre Therapeutics
Spyre Therapeutics is a biotechnology business that is developing a strong pipeline of antibody therapies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$835M2025-10-13Post Ipo Equity· $275M
2024-11-18Post Ipo Equity· $200M
2024-03-18Post Ipo Equity· $180M
Leadership Team
Kate Chevlen
Chief Commercial Officer
Sheldon Sloan
Chief Medical Officer
Recent News
thefly.com
2026-01-03
2025-12-01
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