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Clinical Scientist, Clinical Development

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

đź’µ $175k - $205k / year

⏰ Full Time

🟡 Mid-level

đźź  Senior

đź§Ş Clinical Research

Where this job comes from

Posted on Spyre Therapeutics's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of Spyre Therapeutics

Spyre Therapeutics

11 - 50 employees

🏥 Healthcare

đź’Ľ Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Spyre Therapeutics is a biopharmaceutical company focused on developing therapies for Inflammatory Bowel Disease (IBD). The company is committed to creating best-in-class antibodies, rational therapeutic combinations, and employing precision immunology approaches to enhance treatment efficacy and convenience for IBD patients. With a team experienced in developing and commercializing treatments across various diseases, Spyre Therapeutics is dedicated to improving treatment options and outcomes for patients through advanced research in immunology. The company fosters a collaborative and innovative environment to achieve its mission of providing promising new treatment options for IBD.

đź“‹ Description

• Design, execute and interpret clinical trials supporting development of novel antibody-based therapies • Collaborate with clinical operations, data management, CROs, regulatory, translational science and biomarker teams • Review clinical trial data to identify trends, clean discrepancies and ensure patient safety and protocol compliance • Review adverse events, laboratory data, concomitant medications, medical histories and clinical data queries • Assist with Medical Monitor responsibilities • Contribute to study design and protocol amendments • Author and support submission of protocols, regulatory filings and related documentation • Support site selection, study start-up, trial metric monitoring, risk-based quality oversight and study close-out • Write and review abstracts, posters, scientific meeting content, presentations and publicly distributed materials • Write clinical science sections of meeting packages and support clinical documentation for regulatory submissions • Collaborate with Regulatory Affairs to ensure FDA/ICH and GCP-aligned study designs • Develop and maintain protocols, clinical study reports, investigator brochures and informed-consent forms • Monitor the competitive and scientific therapeutics landscape and contribute to strategic positioning of pipeline programs • Perform additional duties as assigned

🎯 Requirements

• 5+ years of clinical development experience in the biotech/pharma industry • Ideally, 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 • Demonstrated experience executing clinical trials in IBD or another I&I therapeutic area • Understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints • Familiarity with FDA/ICH guidelines and Good Clinical Practice (GCP) • Proven ability to work cross-functionally in a matrix organization • Excellent written and verbal communication, 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

🏖️ Benefits

• Market competitive compensation and benefits package • Performance bonus • Equity grant opportunities • Health benefits • Welfare benefits • Retirement benefits • Unlimited PTO • Two, one-week company-wide shutdowns each • Professional development opportunities • Remote working environment with frequent in-person meetings • Opportunity to work in a fast-paced, dynamic environment, contribute broadly to advance meaningful medicines, and learn quickly

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