Associate Director, Device Clinical Development

Role Summary

The Associate Director of Device Clinical Development (DCD) provides strategic clinical leadership for global device and combination product development programs, overseeing device clinical and risk management strategies, training frameworks, and adherence to design control principles while collaborating across multidisciplinary teams to meet quality and regulatory standards.

Responsibilities

• Device Clinical Strategy & Risk Management: Develop device clinical development strategy for combination products and medical devices; create risk management strategies including hazard analysis; translate clinical and user needs into technical requirements; coordinate risk mitigation across clinical, regulatory, quality, and engineering; perform safety reviews from trials and field.
• Training Development: Design evidence-based product use training for patients, healthcare professionals, and trial staff; develop innovative instructional methodologies; establish metrics to evaluate training effectiveness and drive continuous improvement.
• Clinical Quality Assurance & Compliance: Implement quality management systems for clinical activities; develop and maintain clinical SOPs and trial-related device documentation; support quality audits and CAPAs.
• Clinical Trial Support: Develop device-specific training materials and trial protocols; implement train-the-trainer programs; provide real-time clinical guidance on device-related aspects during trials.
• Design Control Adherence: Ensure clinical input throughout design controls; review/approve user requirements, design specs, and verification/validation plans; maintain traceability between clinical needs and technical specs.
• Human Factors & Usability: Support use workflow development and usability engineering; support formative and summative human factors study training.
• Regulatory Engagement: Support audits by internal teams and Health Authorities; prepare clinical sections for regulatory submissions; represent clinical perspectives in regulatory meetings.
• Vendor Management: Provide SME mentorship to vendors; establish oversight frameworks and performance metrics; conduct vendor qualification and evaluation.
• Cross-functional Collaboration: Facilitate integration between clinical and device development teams; coordinate with Global Device Team across engineering, regulatory, quality, and commercial functions; align interdepartmental initiatives to optimize timelines.
• Process Innovation: Lead initiatives to improve efficiency of clinical development processes; apply data-driven approaches to optimize activities; develop innovative solutions to streamline development.
• Team Leadership & Development: Promote scientific excellence and adherence to regulatory/quality standards; mentor and develop the device clinical development organization.

Qualifications

• Advanced degree in medical, clinical, healthcare science, or related field; Doctorate with 7+ years, or Master’s with 13+ years, or Bachelor’s with 15+ years of experience
• Minimum 5 years of experience in combination product, medical device, or pharmaceutical industry
• Experience with medical devices, drug-device combination products, and digital health technologies across multiple therapeutic areas
• Experience with device design control processes and risk management methodologies
• Thorough understanding of FDA, EMA, and international regulations for medical devices and combination products
• Proven ability to thrive in a fast-paced environment supporting multiple development programs

Preferred Qualifications

• Health Care Provider practicing part-time (no more than 5 days per month) preferred
• Advanced program management skills
• Strong background in clinical research methodology
• Exceptional stakeholder management and conflict resolution capabilities