At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As an Associate Director Device Development in Durham, NC, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

The Associate Director Device Development reports to the Sr. Director of Device Development and works within our Inhalation Product Development (IPD) team in Research Triangle Park North Carolina.  This person will lead and support all design and development aspects of new device (Medical Device and Combination Product) development projects, and post-marketing support, ensuring work meets internal and external Design Control requirements. The role also requires project management skills, a thorough understanding of design work and design control procedures, and close collaboration with other AZ functions, external suppliers and consulting partners.  The ideal candidate will have extensive device engineering experience in combination products, including combination inhalation products, and a working knowledge of medical device design controls.  In addition, the candidate should have strong problem solving and communication skills with the drive and hands-on leadership qualities needed to deliver on challenging project goals.  Experience authoring US and international regulatory documents is desired.

Responsibilities include:

• Effectively lead, guide, manage, and mentor a team of internal and external technical resources to deliver Medical Device and Combination Products including state of the art inhalation devices
• Define, monitor, and manage project budgets, spending, and resource plans
• Responsible for the planning and coordination of all device project team activities, translating strategy into cross-functional integrated project plans
• Accountable for product development-related device regulatory sections filed across global markets (e.g., IND, NDA, IMPD, MAA, JNDA, etc.)
• Propose innovative solutions to agreed to strategic challenges
• Maintaining a network of contacts across Operations, Clinical, and other key AZ groups for the use of connected inhalers in both clinical and commercial settings. Contribute to the internal networks in the Device/Medical Device area
• Anticipate and manage project risks and issues, and provide specific mitigation and corrective action strategies
• Facilitate project team meetings, set agendas, publish meeting minutes, and follow-up on action items
• Develop presentations and communicate project status against key project milestones and budget for a broad set of stakeholders
• Ad-hoc projects as needed
• May require travel of 10-20% of working time

Qualifications:

Education:

• Depending on direct experience, PhD – 10+ years, MS – 12+ years, BS – 15+ years of relevant industry experience.  Degree in Mechanical, Electrical, or Biomedical Engineering, or a similar applicable discipline.

Required:

• Minimum of five (5) years of project leadership or management experience, ideally within medical devices or combination products
• Proven record of successful development leadership, project planning, and problem-solving in the area of inhalation products and/or medical devices, including working with a sense of urgency to meet project goals
• Proven experience managing multiple projects and/or programs concurrently
• Extensive experience with Design Control, ideally with combination products
• Skilled leader of cross-functional teams with senior specialists and highly skilled employees
• Knowledge across the entire development process from concept phase through development, regulatory submission and approval, transfer, and launch
• Strong oral and written communication skills.  Expert knowledge of MS Excel, Outlook, PowerPoint, Word and proficient in MS Project

Preferred:

• Direct experience in inhalation device development
• Experience working with hardware/software-based product development, ideally within connected devices or iOT
• Energized by a lean and fast-paced work environment
• Demonstrated proficiency managing rapidly changing priorities and aggressive timelines
• Demonstrated ability to monitor, manage, and grow diverse external partnerships

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

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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.