Sr. Director, Combination Drug Product/Device

Role Summary

Sr. Director, Combination Drug Product/Device. 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. Advises senior leadership on device development strategies while mentoring cross-functional engineering teams.

Responsibilities

• 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)

Qualifications

• 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