In partnership with the broader CMC organization, the Associate Director of Drug/Device Combination Products will lead the development and lifecycle strategy for drug/device combination products, including prefilled syringe and autoinjector presentations. This role will provide technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post‑approval lifecycle management. The successful candidate will serve as a subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration. This individual will work closely with cross‑functional partners across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external development and manufacturing partners to advance a pipeline of injectable products.

Responsibilities

Lead strategic planning and execution of drug/device combination product development for clinical and commercial presentations
Provide technical ownership for delivery devices, primary packaging, and related combination product elements across the product lifecycle
Develop and implement innovative delivery device solutions, including prefilled syringe, autoinjector, and other injectable delivery platforms
Serve as the device and combination product subject matter expert on cross‑functional CMC and program teams
Lead technical decision‑making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management
Ensure timely completion of development, verification, validation, manufacturing, and technology transfer deliverables
Partner with Quality, Regulatory, and external suppliers to ensure combination product strategies meet global regulatory, cGMP, safety, and quality expectations
Identify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization activities
Monitor external innovation, emerging technologies, connected health solutions, and industry trends in injectable delivery systems
Support integration of delivery device and drug product strategies across multiple therapeutic modalities, including peptides, proteins, antibodies, and gene therapy products

Requirements

BS/BA in Mechanical Engineering, Biomedical Engineering, or a related field, with 10+ years of industry experience, OR MS/MA in Mechanical Engineering, Biomedical Engineering, or a related field, with 8+ years of industry experience, OR PhD in Mechanical Engineering, Biomedical Engineering, or a related field, with 5+ years of industry experience
Demonstrated expertise in medical device or combination product development, engineering, and commercialization
Experience developing combination products leveraging complex mechanical or electromechanical delivery systems, preferably including prefilled syringes, autoinjectors, on‑body delivery systems, or related injectable platforms
Advanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle management
Experience with drug/device integration, manufacturing scale‑up, technology transfer, and external partner or supplier oversight
Thorough understanding of cGMP, quality systems, and global regulatory expectations for combination products and medical devices, including FDA, EMA, and applicable ISO standards
Current knowledge of drug delivery technologies, connected health solutions, human factors/usability engineering, and emerging trends in injectable product development
Proven ability to solve complex technical challenges, make sound risk‑based decisions, and influence cross‑functional teams
Strong communication, collaboration, and leadership skills in a matrixed environment

Preferred Qualifications

Experience supporting regulatory filings, health authority interactions, or commercial launch readiness for combination products
Experience working with external device developers, contract manufacturers, testing laboratories, or component suppliers
Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies
Experience supporting products across multiple modalities, including peptides, proteins, antibodies, or gene therapy products

Compensation and Benefits

The annual base salary is expected to be $173,600.00-$237,000.00, with a target bonus of 30% of earned base salary and eligibility to participate in our equity‑based long‑term incentive program. Benefits 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.

EEO Statement

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.

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