72 applicants

Company

Spyre Therapeutics · 1 day ago

Senior Director, Device Development

US- Remote

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$250K/yr - $275K/yr

10+ years exp

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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

Identifies novel and nascent technically innovative opportunities, developing IP as appropriate

Other duties as assigned

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Device DevelopmentDrug-Device Combination ProductsISO13485Regulatory StandardsData Analysis ToolsExperience in Start-up EnvironmentMentoring Experience

Required

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

Preferred

Experience in a small company or start-up environment

Benefits

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.