GILEAD
Associate Director Of Device Development
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are seeking a people-focused and technically strong Associate Director of Device Development to lead a team of engineers in the design and development of parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This role is a first-line people manager position, responsible for developing talent, fostering a collaborative and high-performing team culture, and ensuring successful execution of device development programs. The ideal candidate will bring a balance of technical leadership, strategic thinking, and people management to drive innovation and execution across the portfolio. Key Responsibilities Lead, manage, and develop a team of engineers, providing coaching, performance feedback, and career development support. Foster a culture of collaboration, accountability, and continuous improvement within the device development function. Oversee technical execution of combination product development programs, ensuring alignment with design control and regulatory requirements. Ensure high-quality documentation, including design inputs/outputs, verification, validation, and risk management deliverables. Contribute to regulatory submissions, including INDs, NDAs, and other global filings. Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on strategy, timelines, and risk mitigation. Support technology transfer to clinical and commercial manufacturing sites. Drive problem-solving and root cause analysis for product quality investigations and change control activities. Represent the team and function in internal and external meetings, including with suppliers and partners. Basic Qualifications Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience Preferred Qualifications Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Minimum of 10+ years (BS) or 8+ years (MS) of relevant industry experience in combination product development. Prior experience managing or mentoring engineers in a technical environment is required. Strong understanding of design control, risk management, and regulatory standards (FDA, EMA, ISO 13485, ISO 14971, cGMP). Proven ability to lead teams, manage performance, and build a positive team culture. Excellent communication and interpersonal skills; able to influence across functions and levels. Demonstrated ability to solve complex problems and make decisions aligned with organizational goals.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description We are seeking a people-focused and technically strong Associate Director of Device Development to lead a team of engineers in the design and development of parenteral drug-device combination products, including autoinjectors, prefilled syringes, and needle safety systems. This role is a first-line people manager position, responsible for developing talent, fostering a collaborative and high-performing team culture, and ensuring successful execution of device development programs. The ideal candidate will bring a balance of technical leadership, strategic thinking, and people management to drive innovation and execution across the portfolio. Key Responsibilities Lead, manage, and develop a team of engineers, providing coaching, performance feedback, and career development support. Foster a culture of collaboration, accountability, and continuous improvement within the device development function. Oversee technical execution of combination product development programs, ensuring alignment with design control and regulatory requirements. Ensure high-quality documentation, including design inputs/outputs, verification, validation, and risk management deliverables. Contribute to regulatory submissions, including INDs, NDAs, and other global filings. Collaborate cross-functionally with Regulatory, Quality, Clinical, and Manufacturing teams to align on strategy, timelines, and risk mitigation. Support technology transfer to clinical and commercial manufacturing sites. Drive problem-solving and root cause analysis for product quality investigations and change control activities. Represent the team and function in internal and external meetings, including with suppliers and partners. Basic Qualifications Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience Preferred Qualifications Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Minimum of 10+ years (BS) or 8+ years (MS) of relevant industry experience in combination product development. Prior experience managing or mentoring engineers in a technical environment is required. Strong understanding of design control, risk management, and regulatory standards (FDA, EMA, ISO 13485, ISO 14971, cGMP). Proven ability to lead teams, manage performance, and build a positive team culture. Excellent communication and interpersonal skills; able to influence across functions and levels. Demonstrated ability to solve complex problems and make decisions aligned with organizational goals.