Senior Director, Device Development

As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release

The right candidate will lead a Device Development group that develops combination products from concept to commercialization for the AstraZeneca biologics portfolio. The scope of this role includes leading a group of Device Team Leads and Device Engineers to develop new technologies and advance pipeline programs through clinical studies and toward commercial launch. This position requires significant interaction with AstraZeneca leaders and functional areas, including research and development, formulation development, drug product process development, manufacturing operations, regulatory, quality, marketing and procurement organizations as well as CMC Teams and Global Project Teams.  You will represent AstraZeneca with external device partners.  This individual will effectively lead in a matrix environment and be able to influence broadly internally and externally.

Major Duties and Responsibilities

• Lead scientific and technical development of devices and combination products from concept to commercialization

• Provide oversight of a device engineering group ensuring that development strategies, engineering work, design controls activities, and regulatory filings meet the organizational needs.  

• Provide leadership and work with senior leaders across the therapeutic areas to build device technology and development strategies that meet the portfolio and market needs

• Drive the assessment, selection and development of new technologies/platforms that meet the needs of R&D portfolio and therapeutic area strategies

• Challenge and build strong relationships and partnerships with key interfaces such as research, CMC development functions, quality, regulatory, operations and commercial

• Serve as an effective partner internally within Device Development and across AstraZeneca with multi-functional partners

• Broadly influence and educate senior leaders and the larger AstraZeneca functional areas and product teams on the development of combination products

• Ensure regulatory requirements are met and drive improvements in partnership with CMC functions, Quality and Regulatory

• Lead and mentor leaders and develop people

Education
B.S., M.S. or Ph.D. in chemical/mechanical engineering, materials science, biomedical engineering or related field with 12+ years of related experience in the combination product or medical device industry.  Strong technical and scientific skills with validated experience in development of combination products from concept to commercialization. 

Requirements

• Candidate must have a record of success developing combination products

• Must have a recognized external presence which can include patents, scientific publications, invitations to participate in industry/regulatory meetings and working groups, and development of innovative technical / regulatory strategies

• Must have a strong, broad understanding of competitive landscape, marketed product trends and industry technology advancements

• Must possess in depth knowledge developing and executing strategies for drug delivery systems / devices

• Experience in the CMC aspects of biopharmaceutical development

• In-depth knowledge of and expertise with US and worldwide device regulations; must have experience interacting with health authorities

• Candidate must have an established external network with device companies and consultants; must have experience leading external activities and collaborations with partners

• Demonstrated ability to partner and lead / influence multi-functionally and at a senior level within the organization, including direct experience working with senior leadership teams

• Proven ability to efficiently lead professional staff and work in a collaborative team environment across multiple technical functions

When we put unexpected teams in the same room, we ignite ambitious 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 expe