Neurocrine Biosciences
Sr. Director, Combination Drug Product/Device
Neurocrine Biosciences, San Diego, California, United States, 92189
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders.
About The Role Strategic expert in medical device development and drug-device combination products who develops innovative delivery systems including autoinjectors and prefilled syringes. Leads product development from concept to launch, managing design, verification, technology transfer, and regulatory submissions. Your Contributions
Direct strategic planning and implementation of drug/device combination product development for preclinical and clinical candidates Create and implement innovative delivery device solutions from preclinical through commercial stages Lead device development projects and represent device expertise on cross-functional teams Supervise engineering personnel and guide their professional development Ensure timely completion of R&D and manufacturing deliverables for combination products Solve complex technical challenges related to delivery devices and drug product integration Engage with external partners and present at industry forums Mentor junior engineers and team members Lead drug product development strategies through partnerships and integrate products across modalities (peptides, proteins, antibodies, gene therapy) Requirements
BS/BA with 15+ years of experience, OR MS/MA with 13+ years of experience, OR PhD (or equivalent) with 10+ years of experience Recognized thought leader in drug/device combination product development Expert in advanced medical device development and pharmaceutical integration Creative problem-solver for complex technical challenges Industry influencer on matters affecting Neurocrine's business Skilled mentor with strong leadership abilities for direct and matrix teams Demonstrated ability to convert strategic vision into actionable plans with measurable outcomes Expert in medical device engineering and drug delivery systems Current knowledge of device technology, connected health solutions, and drug delivery advances Technical design expertise for complex mechanical and electromechanical delivery systems Experience with drug/device manufacturing and technology transfer Advanced knowledge of design controls, verification and validation processes Thorough understanding of cGMP, safety and regulatory requirements (FDA, EMA, ISO) Cross-functional expertise in combination product development Proven team leadership in device development programs Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. The annual base salary we reasonably expect to pay is $219,700.00-$318,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
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Direct strategic planning and implementation of drug/device combination product development for preclinical and clinical candidates Create and implement innovative delivery device solutions from preclinical through commercial stages Lead device development projects and represent device expertise on cross-functional teams Supervise engineering personnel and guide their professional development Ensure timely completion of R&D and manufacturing deliverables for combination products Solve complex technical challenges related to delivery devices and drug product integration Engage with external partners and present at industry forums Mentor junior engineers and team members Lead drug product development strategies through partnerships and integrate products across modalities (peptides, proteins, antibodies, gene therapy) Requirements
BS/BA with 15+ years of experience, OR MS/MA with 13+ years of experience, OR PhD (or equivalent) with 10+ years of experience Recognized thought leader in drug/device combination product development Expert in advanced medical device development and pharmaceutical integration Creative problem-solver for complex technical challenges Industry influencer on matters affecting Neurocrine's business Skilled mentor with strong leadership abilities for direct and matrix teams Demonstrated ability to convert strategic vision into actionable plans with measurable outcomes Expert in medical device engineering and drug delivery systems Current knowledge of device technology, connected health solutions, and drug delivery advances Technical design expertise for complex mechanical and electromechanical delivery systems Experience with drug/device manufacturing and technology transfer Advanced knowledge of design controls, verification and validation processes Thorough understanding of cGMP, safety and regulatory requirements (FDA, EMA, ISO) Cross-functional expertise in combination product development Proven team leadership in device development programs Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. The annual base salary we reasonably expect to pay is $219,700.00-$318,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
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