Associate Director, Device Clinical Development

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Job Description

About the Role:

The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive product training frameworks, and ensuring rigorous adherence to design control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards.

Core Responsibilities:

Device Clinical Strategy & Risk Management:

• Develop Device Clinical Development Strategy for Combination Products and Medical Devices

• Develop comprehensive risk management strategies for devices and combination products including patient harm assessment in Hazard Analysis

• Support translation of clinical and user needs into technical requirements

• Coordinate risk mitigation activities across clinical, regulatory, quality, and engineering functions

• Perform safety reviews on device and combination products from clinical trials and from the field

Training Development:

• Design evidence-based product use training programs for patients, healthcare professionals, and clinical trial staff

• Develop innovative instructional methodologies aligned with developmentally tailored learning principles

• Establish metrics to evaluate training effectiveness and implement continuous improvement

Clinical Quality Assurance & Compliance:

• Implement quality management systems for clinical activities related to device development

• Develop and maintain clinical SOPs and clinical trial related device documentation

• Support quality audits and implement corrective and preventive actions (CAPAs)

Clinical Trial Support:

• Develop device-specific training materials and review protocols for clinical trials

• Implement train-the-trainer programs for clinical research sites

• Provide real-time clinical guidance on device-related aspects during trials

Design Control Adherence:

• Ensure clinical input is incorporated throughout the design control processes

• Review and approve user requirements, design specifications, and verification/validation plans

• Maintain traceability between clinical needs and technical specifications

Human Factors & Usability:

• Support use workflow development and usability engineering processes

• Support formative and summative human factors study training

Regulatory Engagement:

• Support audits from internal teams and Health Authorities related to device clinical development

• Prepare clinical sections for regulatory submissions (IDE, 510(k), PMA, IND, NDA, BLA)

• Represent clinical perspectives in regulatory meetings and correspondence

Vendor Management:

• Provide subject matter expertise and mentorship to vendors performing clinical functions

• Establish vendor oversight frameworks and performance metrics

• Conduct vendor qualification, selection, and performance evaluation

Cross-functional Collaboration:

• Facilitate seamless integration between