Director, Device Project Management
About The Position
The Device Project Management Group drives AstraZeneca device project delivery for clinical studies and commercial launches of parenteral combination products. The group plans, coordinates, and delivers product activities against project requirements and timelines; plans and monitors development resources and expenses; and performs strategic planning for platforms and novel processes. It works globally with CMC, Drug Product, Operations, Quality, Regulatory, and other development functions. The Director leads a group of project managers and collaborates with Device Team Leads and CMC project managers to achieve project goals and milestones and align device activities with overall CMC plans. The role works across Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering, Biologics Product Development, and other AstraZeneca functions. It requires effective communication of technical and non-technical information to senior management, health authorities, auditors, and other internal and external stakeholders. The role has high complexity and requires substantial independence with minimal to no supervision. The position is based in Gaithersburg or Boston. The role follows a hybrid working arrangement, with an average expectation of at least three days per week in the office and some flexibility.
Requirements
- Bachelor's, Master's, or PhD in a relevant technical discipline such as Biomedical, Mechanical, or Chemical Engineering, or equivalent industry experience in areas such as Device Development, Regulatory, Quality, or Process Engineering.
- At least 10 years of product development experience.
- At least 5 years of project management experience, with the majority focused on Combination Product Development.
- At least 3 years of experience leading a project management office.
- Experience planning, managing, and executing functional and/or cross-functional aspects of device development for combination products.
- Working knowledge of biopharmaceutical product development.
- Experience managing distributed resources across multiple sites and time zones.
- Strong planning, coordination, teamwork, communication, and interpersonal skills, with commitment, flexibility, and independence.
Nice To Haves
- Advanced degree in a relevant field.
- Professional Project Management certification.
Responsibilities
- Manage the Device Project Management group, including resource and budget management, talent management, and employee development.
- Ensure Combination Product programs are delivered on time, to required quality, within budget, and in accordance with project and company quality standards and AstraZeneca strategy.
- Serve as a subject-matter resource for device project management strategy and the interpretation and application of Design Controls.
- Facilitate the planning, execution, and approval of Design Control deliverables.
- Develop and maintain processes, tools, and technology to lead a portfolio of projects effectively.
- Manage projects to ensure plans are optimal and aligned with strategic goals and clinical and commercial development plans.
- Introduce new approaches to project leadership and planning using available systems and resources.
- Lead and implement strategic initiatives related to Device Project Management and Combination Product Development.
- Communicate technical and non-technical materials effectively to company senior management and leaders, health authorities, auditors, and other stakeholders.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Director
