Director, Device Project Management

Summary of the group:

The Device Project Management Group drives AstraZeneca device project delivery, supporting clinical studies and commercial launch for AstraZeneca’s parenteral combination products. Device Project managers plan, coordinate, and deliver combination of product 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.

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 other areas of Biologics Product Development and 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 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.

LOCATION: Gaithersburg or Boston

Main Duties & Responsibilities:

• Manages the Device Project Management group, including resource management, budget management, talent management, and employee development accountability

• Responsible for ensuring Combination Product programs 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

• Manages projects to ensure plans are optimal and meet overall strategic goals aligned with clinical and commercial development plans

• Introducing new ways of leading and planning projects through use of available systems and resources

• Leads and implements strategic initiatives related to Device Project Management and Combination Product Development

Education & Experience Requirements:

• Education: Bachelor's, Master's, or PhD in relevant technical disciplines such as Biomedical, Mechanical, or Chemical Engineering, or equivalent industry experience such as Device Development, Regulatory, Quality, or Process Engineering
• Experience: 10+ years’ product development experience. 5+ years of Project Management experience (with the majority focused on Combination Product Development)

• 3+ years of experience leading a project management office

• Successful candidates must have experience in planning, managing, and executing functional and/or cross functional aspects of device development in the context of combination products and a working knowledge of biopharmaceutical product development

• Experience managing distributed resources across multiple sites and time zones

Education & Experience Requirements:

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

• Experience: 10+ years’ product development experience. 5+ years of Project Management experience (with the majority focused on Combination Product Development)

• 3+ years of experience leading a project management office

• Successful candidates must have experience in planning, managing, and executing functional and/or cross functional aspects of device development in the context of combination products and a working knowledge of biopharmaceutical product development

• Experience managing distributed resources across multiple sites and time zones

Desired Skills:

• Advanced degree within field

• 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 ambitious world.

The annual base pay (or hourly rate of compensation) for this position ranges from $159,369 to $239,054. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Why AstraZeneca:

Here you will contribute to a bold mission to transform outcomes for people by advancing earlier detection and smarter, faster trials. You will operate at the intersection of innovative science and technology, backed by significant investment and an empowered, collaborative culture that brings clinicians, scientists, and data experts together to accelerate breakthroughs. We value kindness alongside ambition, giving you the trust, tools, and cross-functional partnerships to lead with confidence and shape studies that matter—so your decisions today translate into meaningful patient impact tomorrow.

Call to Action:

Step into this country leadership role to accelerate life-changing trials and turn bold science into result that matter—make your move and help shape what comes next.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.