Senior Director, Device Development
: Job Details :

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 ReleaseThe 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 ResponsibilitiesLead scientific and technical development of devices and combination products from concept to commercializationProvide 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 needsDrive the assessment, selection and development of new technologies/platforms that meet the needs of R&D portfolio and therapeutic area strategiesChallenge and build strong relationships and partnerships with key interfaces such as research, CMC development functions, quality, regulatory, operations and commercialServe as an effective partner internally within Device Development and across AstraZeneca with multi-functional partnersBroadly influence and educate senior leaders and the larger AstraZeneca functional areas and product teams on the development of combination productsEnsure regulatory requirements are met and drive improvements in partnership with CMC functions, Quality and RegulatoryLead and mentor leaders and develop peopleEducationB.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. RequirementsCandidate must have a record of success developing combination productsMust 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 strategiesMust have a strong, broad understanding of competitive landscape, marketed product trends and industry technology advancementsMust possess in depth knowledge developing and executing strategies for drug delivery systems / devicesExperience in the CMC aspects of biopharmaceutical developmentIn-depth knowledge of and expertise with US and worldwide device regulations; must have experience interacting with health authoritiesCandidate must have an established external network with device companies and consultants; must have experience leading external activities and collaborations with partnersDemonstrated ability to partner and lead / influence multi-functionally and at a senior level within the organization, including direct experience working with senior leadership teamsProven ability to efficiently lead professional staff and work in a collaborative team environment across multiple technical functionsWhen 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 expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.#LI-HybrWhy AstraZeneca?We follow the science to explore and innovate, working towards treating, preventing, modifying and even curing some of the world's most complex diseases. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. Here you will work with curious minds in an inclusive culture where all doors are open, every voice is heard, and we are forever expanding our horizons.Ready to make an impact on patients' lives? Join us at AstraZeneca where we are pushing the boundaries of science to deliver life-changing medicines. Apply now!Date Posted10-Nov-2024Closing Date23-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Boston - MAType: Full time