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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 clinical functions and device development teams

+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality, and commercial functions

+ Coordinate interdepartmental initiatives to optimize device clinical development 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 a culture of scientific excellence, adherence to regulatory and quality standards, and patient-focused innovation.

+ Lead, mentor, and develop organization on device clinical development best practices, strategies, and trends

Required Qualifications:

+ An advanced degree in medical, clinical, healthcare science, or a related field:

Doctorate degree with 7+ years of experience, OR

Master's degree with 13+ years of experience, OR

Bachelor's degree with 15+ years of experience

+ Minimum 5 years of combination product, medical device, or pharmaceutical industry experience

+ Experience with both medical devices, drug-device combination products, 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:

+ A Health Care Provider (HCP) that is practicing part-time (no more than 5 days per month) is strongly preferred

+ Advanced program management skills

+ Strong background in clinical research methodology

+ Exceptional stakeholder management and conflict resolution capabilities

This role offers an exceptional opportunity to drive innovation at the intersection of medical devices and pharmaceutical development, with significant impact on patient care and treatment outcomes.​​​​​​​​​​​​​​​​

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

$153,600.00 - $241,340.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.