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Sr. Director, Combination Drug Product / Device

Sr. Director, Combination Drug Product / Device

Neurocrine BiosciencesSan Diego, CA, US
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Strategic Expert In Medical Device Development

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.

The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis

  • and uterine fibroids,
  • as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science.

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. Possesses extensive knowledge of engineering principles and materials science. Advises senior leadership on device development strategies while mentoring cross-functional engineering teams.

Your Contributions (Include, But Are Not Limited To) :

  • 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. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

    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. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver / parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

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