Clinical Scientist, Clinical Development

Ideal Candidatenice to have

• 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.
• Bachelor's degree in life sciences, clinical pharmacology, immunology or related discipline; advanced degree is a plus.
• Demonstrated experience in executing clinical trials IBD or other I&I therapeutic area.
• An 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.

• Collaborate with clinical operations, data management and CRO, with a focus on ongoing clinical data review, to identify data trends, clean discrepancies, and ensure patient safety and protocol compliance.
• Perform regular, systematic reviews of clinical trial data, including adverse events, lab data, concomitant medications, medical histories and resolution of clinical data queries.
• Assist in Medical Monitor responsibilities.
• 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.
• Assist with 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.
• 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.