Senior Director - Device Development

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. • Seeking an experienced Senior Director, Device Development, to lead technical operations for device development including device design, validation and manufacturing.

Requirements

• Master’s degree in engineering with at least 10 years of relevant experience. Equivalent experience equals a bachelor’s degree and 15+ years of relevant experience (PhD and comparable experience may also be considered) • Experience in drug-device combination products and related regulations in the biotech/pharmaceutical/medical device industry. Deep knowledge of ISO13485 and Quality System Requirements, applicable Industry and Regulatory Standards and Guidance Documents • Strong analytical and critical thinking skills • Proficient in data analysis tools and software • Detail-oriented with a knack for identifying trends and anomalies • Strong leadership skills with experience in managing and mentoring a high-performing team • Excellent communication skills and the ability to work effectively in a fast-paced environment • Experience in a small company or start-up environment is preferred

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.