Senior Clinical Trial Manager - Clinical Operations

2 days ago

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Spyre Therapeutics

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Description

• Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation of inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. • The Senior Clinical Trial Manager (Sr. CTM) is a pivotal role responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. • The Sr. CTM will organize and supervise clinical trials, ensuring they meet all company and regulatory requirements. • The Sr. CTM will collaborate closely with internal R&D team members in addition to external CRO partners to drive successful trial execution to advance the development of our cutting-edge antibody conjugate portfolio ensuring efficacy, safety, and regulatory success.

Requirements

• B.A./B.S. in life sciences or equivalent • A minimum of 8 years of clinical research experience within the pharmaceutical or biotechnology industry, with at least 3+ years managing early phase clinical trials; managing global clinical trials a plus • Inflammation and/or Immunology experience is strongly preferred • Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out • Ability to lead cross functional study teams in a matric organization • Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures • Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions.

Benefits

• 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.