Senior Director, R&D
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Senior Director of Device Development in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Requirements:
Main Duties and Responsibilities
Lead device development for combination products from concept through to commercialization including pre-filled syringes, autoinjectors, pen devices and on-body injectors. This position requires significant interaction within research and development, as well as, collaborating with manufacturing operations, regulatory, and quality organizations and device partners. As such, this individual must be able to 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 biologics devices from concept to commercialization
•Build scientific excellence in device development including people and lab capability; as well as working with operations to ensure manufacturing capability to support the commercial market
•Assess new technologies and bring device solutions matched to the R&D portfolio
•Lead development projects from concept to commercialization working internally and through external device partners
•Transfer technology to operations for commercialization and continue to support devices in the commercial market
•Lead the strategy and prepare regulatory documentation from IND/CTA to BLA/MAA to post-marketing commitments; interact with regulators as needed including preparation for and attending meetings with regulatory agencies as required
•Work with quality to ensure a clinical stage appropriate guidance consistent with the industry
•Mentor and develop junior staff
•Develop leadership in the industry through establishing intellectual property, influencing standards, publications and presentations and representing MedImmune at external events
•Create solid partnerships with key interfaces such as research, quality, regulatory, operations and commercial through participation on leadership teams and projects and representing BPD as needed on governance and network groups
•Influence our projects and organization broadly through participation on the Development Leadership Team
Essential Requirements
Education:
PhD or equivalent in chemical/mechanical engineering, materials science, biomedical engineering or related field plus 15+ years of related experience in the combination product or medical device industry. Strong technical and scientific skills with proven experience in development of combination products from concept to commercialization including device quality management, human factors studies and design verification/validation.
Major Requirements:
•Candidate must be an established industry science leader in biologics combination product development with a record of having taken biopharmaceutical products from design to commercialization, preferentially with a variety of device technologies
•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 regulatory strategies
•Candidate must have an established academic and industry network and demonstrate business acumen in industry trends
•Experience in developing strategy and goals within a relevant functional leadership team
•Experience in the CMC aspects of biopharmaceutical development including working knowledge of US and worldwide device regulations
•Experience in leading external activities and collaborations
•Demonstrated ability to lead / influence cross-functionally and at a senior level within the organization, including direct experience working with senior leadership teams
•Demonstrated ability to effectively lead professional staff and work in a collaborative team environment across multiple technical functions
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.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
