Senior Director, Device Development

At AstraZeneca we win through the science it is at the heart of our every success. Every decision is rooted in the limitless possibilities of what science can do. We push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do. It gives us a reason to come to work every day. It reminds us why we exist as a company. It helps us deliver benefits to patients and build new value for shareholders. It also sets the context for our employees activities and the roles of our teams partners and other collaborators. AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds and we nurture and build top talent.

Introduction to role:

Are you ready to lead the charge in device development for Alexion products As the Senior Director Device Development youll be at the forefront of continuous product improvement within the Global Product Development function. This pivotal role involves leading device development activities and being responsible for Device/Combination Product Project development to support the Alexion Portfolio. Youll lead projects support documentation and drive related activities that make a difference!

Accountabilities:

• Lead Device/Combination product projects to support molecules developed by Alexion with cross-functional teams.

• Drive activities related to the project including design control activities design verification and modernization to support coordinated design control activities from clinical development through registration and commercial support.

• Perform deep reviews of the projects with engineers to ensure technical and timing robustness.

• Support Due Diligence for new acquisitions or new device technologies.

• Ensure all designs function as required and align with the Companys quality assurance requirements as well as applicable regulatory requirements.

Essential Skills/Experience:

• Bachelors or Masters in Engineering (Mechanical Electrical Engineering Biomedical or Chemical) plus 10-15 years of experience in medical device development.

• Minimum of 8 years of direct multi-functional program management experience in the development and commercialization of device branded products.

• Mandatory experience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.

• Mandatory working experience in phase-based design control activities with coordinated risk management work and human factors/usability engineering studies from research through registration launch and life cycle management.

  • Demonstrated success leading multi-site global or enterprise-wide programs in the biotech/pharmaceutical industry.

  • Experience in interacting with R&D to understand early Device/Combination product needs and develop roadmaps.

  • Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.

  • Effective communication collaboration and team-building skills; ability to connect with all levels of the organization. Proficient in authoring internal reports project summaries and internal/external presentations.

  • Deep knowledge of the performance safety and regulatory compliance (EU and FDA) requirements of medical device and combination products (e.g. ISO 11608 series ISO 14971 IEC 60601 series IEC 62304 FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements and related FDA guidance).

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $207924 to $311886. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

At AstraZeneca youll find an environment where diversity is celebrated and innovation thrives. Our patient-driven culture is energizing and kind fostering connections that lead to groundbreaking ideas impacting patients lives. We value inclusion and different perspectives ensuring that life-changing ideas can emerge from anywhere. Our commitment to kindness is as strong as our ambition to succeed for those in need. We take pride in giving back to our communities.

Ready to make a difference Apply now and join us on this exciting journey!

Date Posted

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.