Director, Device Project Management

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.

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

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