Spyre Therapeutics (NASDAQ: SYRE) is a biotechnology company aiming to address the needs of the millions of people living with inflammatory bowel disease (IBD) by advancing potentially best-in-class long-acting antibodies, rational therapeutic combinations, and precision immunology approaches. Spyre is advancing a robust portfolio that harnesses both proven and novel mechanisms of action for addressing IBD. The company's two parallel lead programs—SPY001 and SPY002—target ?4ß7 and TL1A, respectively, and build upon the validation of these targets by existing commercial- and clinical-stage antibody therapeutics. The company's SPY001 program entered the clinic in June 2024 and the other lead program, SPY002, is projected to enter clinical studies in 2024.
Role Summary
We are seeking an experienced Senior Director, Device Development, to join our growing Technical Operations team. This is a key leadership role on the Technical Operations Leadership Team and will report directly to the Chief Technical Officer. This individual will be responsible for leading technical operations for device development including device design, development, validation and manufacturing throughout the product lifecycle. This role provides the opportunity to build the device organization in coordination with various teams including drug product, commercial corporate strategy, analytical sciences, supply chain, clinical operations, regulatory, quality, and management.
Key Responsibilities
• Lead in the development of new and innovative device technologies, processes, solutions, and products
• Direct people management responsibility internally and external resources to develop, test and manufacture devices/combination products
• Responsible for successful integration of device development, combination product verification and validation testing in clinical development and commercial launch plans
• Search and evaluate external landscape for drug delivery device technologies to recommend device strategies for clinical and commercial assets
• Liaise with external partners to ensure on-time and high-quality execution of development and manufacturing activities for clinical and commercial assets, and commercial supplies continuity
• Inform regulatory strategies, author and/or approve regulatory filings and briefing documents, and represent Spyre in face-to-face meetings with regulatory agencies as needed
• Identify novel and nascent technically innovative opportunities, developing IP as appropriate
• Other duties as assigned
Ideal Candidate
• 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
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 year.
• 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 $250,000 to $275,000. Actual pay offered may vary depending on job-related knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
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