Role Summary:As a Clinical Scientist at Spyre Therapeutics, you will play a key role in designing, executing, and interpreting clinical trials that support development of our novel antibody-based therapies. You will collaborate across functions (clinical operations, regulatory, translational science, biomarker teams) to ensure robust study designs, high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams, external investigators and CRO partners. You will ensure the integrity, safety, and scientific validity of data collected during clinical studies.
Key Responsibilities:- 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.
Ideal Candidate:- 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.
What We Offer:- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- 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.
The expected salary range offer for this role is $175,000 to $205,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
