Director (Device Project Management)

Director (Device Project Management)

Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

About AstraZeneca in Boston, MA and Gaithersburg, MD:

Our AstraZeneca facilities create life-changing medicines for people around the world. Our Gaithersburg and Boston campuses play host to some of the most innovative technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.

Summary of the group:

The Device Project Management Group drives AstraZeneca device project delivery, supporting clinical studies and commercial launch. Device Project managers plan, coordinate, and deliver Device activities in line with project requirements and timelines; plan and monitor resources and expenses for product development; and perform strategic planning for platform and novel processes. The group interfaces globally with the CMC team, Drug Product team, Operations, Quality, Regulatory, and all development functions.

Summary of the position:

The Director of Device Project Management will lead a group of project managers. You will work collaboratively with the Device Team Leads to ensure project goals and milestones are achieved, as well as the CMC PMs to ensure that Device activities align with the overall CMC Plans. You must effectively collaborate with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development at AstraZeneca. Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management/Leaders, health authorities, audits and other internal and external stakeholders. This role has a high job complexity and the successful candidate must have a high level of independence to meet the requirements outlined below with minimal to no supervision.

Main Duties & Responsibilities:

• Leads the Device Project Management group, including resource management, budget management, talent management, and employee development accountability
• Responsible for ensuring Device projects are delivered to time, quality, budget, project standards, company quality standards, and align with AstraZeneca's strategy
• Acts as a source of knowledge in area of expertise associated with defining, communicating and implementing device project management strategy as well as interpreting and applying Design Controls. Facilitates the planning, execution, and approval of Design Control Deliverables
• Develops and maintains processes, tools, and technology required to effectively lead a portfolio of projects
• Leads projects to ensure plans are optimal and meet overall strategic goals aligned with clinical and commercial development plans
• Introduces new ways of leading and planning projects through use of available systems and resources
• Leads and implements critical initiatives related to Device Project Management and Combination Product Development

Education & Experience Requirements:

Education: Bachelor's, Master's, or PhD in a relevant technical discipline such as Biomedical, Mechanical, or Chemical Engineering or related field or equivalent industry experience such as Device Development, Regulatory, Quality, or Process Engineering

Experience: Bachelor's or Master's Degree and 12 years of product development experience -OR- PhD and 8 years of product development experience

Required Skills & Experience:

• 3 years of experience leading a project management office
• Successful candidate must have experience in planning, managing, and executing functional and/or cross functional aspects of device development and a working knowledge of biopharmaceutical product development
• Experience managing distributed resources across multiple sites and time zones
• Ability to assess scientific data and must be comfortable with ambiguity
• Excellent oral and written communication, interpersonal, analytical, and computer skills.
• Effective problem solving and analytical skills to address and handle a broad range of issues and projects and deliver innovative solutions
• Must be highly organized and detail-orientated while being able to work independently on multiple tasks in a fast-paced environment
• Must have experience in planning and leading the cross functional aspects of Device product development
• Must have demonstrated knowledge and application of Project Management tools
• Experience managing and developing project managers
• Experience managing departmental budget and resource planning
• Portfolio management experience

Desired Skills:

• Advanced degree within field preferred
• Professional Project Management certification
• A high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what's next?

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it's yours.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.