Takeda
Associate Director, Device Clinical Development
Takeda, Lexington, Massachusetts, United States, 02173
Associate Director, Device Clinical Development
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 role orchestrates device clinical and risk management strategies, establishes product training frameworks, and ensures adherence to design control principles, while collaborating across multidisciplinary teams to deliver device clinical outcomes that meet quality benchmarks and regulatory standards.
Location and Compensation Location: Lexington, MA
U.S. Base Salary Range: $153,600.00 - $241,340.00 per year
Base pay range and compensation details are provided by Takeda and may vary by skills and experience.
Responsibilities
Device Clinical Strategy & Risk Management: Develop device clinical development strategy for combination products and medical devices; create comprehensive risk management strategies including patient harm assessment in hazard analysis; translate clinical and user needs into technical requirements; coordinate risk mitigation across clinical, regulatory, quality, and engineering functions; perform safety reviews on devices and combination products from clinical trials and 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 learning principles; establish metrics to evaluate training effectiveness and drive continuous improvement.
Clinical Quality Assurance & Compliance: Implement quality management systems for clinical activities related to device development; develop and maintain clinical SOPs and trial-related device documentation; support quality audits and implement 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 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; 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; establish vendor oversight frameworks and performance metrics; conduct vendor qualification, selection, and performance evaluation.
Cross-functional Collaboration: Facilitate integration between clinical functions and device development teams; serve as clinical liaison to Global Device Team across engineering, regulatory, quality, and commercial functions; coordinate interdepartmental initiatives to optimize timelines.
Process Innovation: Lead initiatives to improve efficiency of clinical development processes; implement data-driven approaches to optimize clinical activities; develop innovative solutions to streamline device clinical development.
Team Leadership & Development: Promote scientific excellence, regulatory and quality adherence, and patient-focused innovation; lead, mentor, and develop the device clinical development organization on best practices, strategies, and trends.
Qualifications
Required: An advanced degree in medical, clinical, healthcare science, or related field.
Doctorate with 7+ years of experience, OR Master’s with 13+ years of experience, OR Bachelor’s with 15+ years of experience.
Minimum 5 years of combination product, medical device, or pharmaceutical industry experience.
Experience with both medical devices and drug-device combination products, including 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.
Ability to thrive in a fast-paced environment supporting multiple development programs.
Preferred Qualifications
Health Care Provider (HCP) practicing part-time (preferred).
Advanced program management skills.
Strong background in clinical research methodology.
Exceptional stakeholder management and conflict resolution capabilities.
Legal and Diversity EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected characteristics in accordance with applicable laws.
Other details: Seniority level – Mid-Senior level; Employment type – Full-time; Job function – Research, Analysis, and Information Technology; Industry – Pharmaceutical Manufacturing.
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Location and Compensation Location: Lexington, MA
U.S. Base Salary Range: $153,600.00 - $241,340.00 per year
Base pay range and compensation details are provided by Takeda and may vary by skills and experience.
Responsibilities
Device Clinical Strategy & Risk Management: Develop device clinical development strategy for combination products and medical devices; create comprehensive risk management strategies including patient harm assessment in hazard analysis; translate clinical and user needs into technical requirements; coordinate risk mitigation across clinical, regulatory, quality, and engineering functions; perform safety reviews on devices and combination products from clinical trials and 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 learning principles; establish metrics to evaluate training effectiveness and drive continuous improvement.
Clinical Quality Assurance & Compliance: Implement quality management systems for clinical activities related to device development; develop and maintain clinical SOPs and trial-related device documentation; support quality audits and implement 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 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; 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; establish vendor oversight frameworks and performance metrics; conduct vendor qualification, selection, and performance evaluation.
Cross-functional Collaboration: Facilitate integration between clinical functions and device development teams; serve as clinical liaison to Global Device Team across engineering, regulatory, quality, and commercial functions; coordinate interdepartmental initiatives to optimize timelines.
Process Innovation: Lead initiatives to improve efficiency of clinical development processes; implement data-driven approaches to optimize clinical activities; develop innovative solutions to streamline device clinical development.
Team Leadership & Development: Promote scientific excellence, regulatory and quality adherence, and patient-focused innovation; lead, mentor, and develop the device clinical development organization on best practices, strategies, and trends.
Qualifications
Required: An advanced degree in medical, clinical, healthcare science, or related field.
Doctorate with 7+ years of experience, OR Master’s with 13+ years of experience, OR Bachelor’s with 15+ years of experience.
Minimum 5 years of combination product, medical device, or pharmaceutical industry experience.
Experience with both medical devices and drug-device combination products, including 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.
Ability to thrive in a fast-paced environment supporting multiple development programs.
Preferred Qualifications
Health Care Provider (HCP) practicing part-time (preferred).
Advanced program management skills.
Strong background in clinical research methodology.
Exceptional stakeholder management and conflict resolution capabilities.
Legal and Diversity EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected characteristics in accordance with applicable laws.
Other details: Seniority level – Mid-Senior level; Employment type – Full-time; Job function – Research, Analysis, and Information Technology; Industry – Pharmaceutical Manufacturing.
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