What are the responsibilities and job description for the Associate Director, Device Clinical Development position at ARIAD?
- Job Level:Senior
- Travel:Minimal (if any)
Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
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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, MAU.S. Base Salary Range:
$153,600.00 - $241,340.00The 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.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesIt 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.Salary : $153,600 - $241,340
