Executive Director, Device Development
The head of Device Development leads a global function in Dosage Form Design and Development located in Boston, Massachusetts and Gaithersburg, Maryland. The Device Development function leads an organization that develops drug delivery devices for the AstraZeneca parenteral product portfolio, including both biologics, novel modalities, and synthetic molecules in CVRM (Cardiovascular, Renal and Metabolic diseases), R&I (Respiratory and Immunology), V&I (Vaccines and Immune therapies) and Oncology R&D. Accountabilities include device technology development, product design and development, and commercial support of marketed products for multiple technology types. The incumbent oversees technology assessment and selection, device design, engineering / characterization, verification, human factors, scale-up, commercialization, regulatory strategy/filings and management of numerous interdependent external device partners. The role entails the oversight of a broad range of device technologies including prefilled syringes, needle safety devices, auto-injectors, on-body wearable devices of various sizes and capabilities - reusable and disposable, single and dual chamber, a range of administration volumes, and drive mechanisms (mechanical and electromechanical). Also included are connected solutions and devices. The head of Device Development must also develop new technologies to meet the changing needs of the business and portfolio, including addressing sustainability, transitioning IV products to subcutaneous, devices to deliver new formulation technologies, digital health, and more.
This position requires interaction with senior leaders of other functional areas, including the therapeutics areas within Biopharma R&D, V&I, Oncology R&D, Quality, Regulatory, Commercial and Operations due to the direct impact of the device on clinical administration, competitiveness in the marketplace, speed of development and launch timing, cost of goods and manufacturability. The head of Device Development drives the development of new technologies and platforms that will help ensure AZ leadership position in the marketplace for existing and emerging biologic modalities. The leader will have established relationships with therapeutic areas for strategic input and technology selection for the portfolio. The individual directly influences and contributes to the dosage form strategy for the AZ portfolio. This individual must possess a strong track record of product development and commercialization. They will be accountable for influencing externally within the biopharmaceutical industry, with device companies, health authorities and International Standards Organization (ISO) for emerging device regulatory requirements and standards.
Major Duties and Responsibilities
- Leadership of organization of ~60 people responsible for the development of a multitude of parental product configurations from concept to commercialization.
- Development and implementation of the technology strategy to ensure AZ products are competitive in the marketplace
- Ensure organization has capabilities and know-how that are critical for ensuring that AZ can deliver on the development of robust, reliable devices in a timely manner for clinical and commercial.
- Build strong relationships and partner with other senior leaders across Oncology R&D, Biopharmaceutical R&D, Commercial, Quality, Supply Chain, Procurement, Regulatory, and AZ Bio-ops to ensure that AZ Biologics drug-device combination product portfolio is progressed
- Partner with Quality and Regulatory and ensure compliance with rapidly emerging expectations in global Device regulatory requirements.
- Stay abreast latest technology advances, commercial competitive landscape, and emerging regulatory requirements.
- Develop and build relationships with external partners including device technology companies and ensure that interdependent components and devices work effectively as a system for robust and reliable device performance in the clinic and marketplace.
- Strong external reputation and influence within the area of expertise as evidenced by active collaborations and network with pharma partners, device partners, industry consortia, ISO, and health authorities.
- Accountability for content of device development sections of regulatory submissions for biologics portfolio for CTAs, MAAs and Notified Bodies.
- Provide input to the AZ parenteral dosage form design and development strategy to ensure alignment with portfolio and AZ business needs. Establish device technology strategy that is linked to Therapeutic Area needs.
- Building and developing a high performing organization and teams, as well as recruiting and developing engineering leaders
- Responsible for performance management of senior managers and for succession planning
- Responsible for managing resources, budget and for making technology investment decisions.
- Serve as a functional represent in R&D governance committees and boards.
Education
Advanced education (Ph.D. or equivalent) in engineering or related field with ideally 15+ years of experience in development and commercialization of drug-device combination products with proven success.
Requirements
- Industry leader in drug + device combination product development for biopharmaceuticals with a record of having taken combination products from design to commercialization. Extensive experience within the pharmaceutical industry and significant understanding of the overall drug + device development and stakeholder management process
- Extensive knowledge of CMC aspects of drug + device combination product development including interactions with regulators and global health authorities
- Established external network with device and pharma companies and experience leading external activities and collaborations
- Ability to influence health authorities, ISO and other industry organizations.
- Experience with development and implementation of innovative technical and regulatory strategies
- Broad understanding of competitive landscape, marketed product trends and industry technology advancements.
- In-depth knowledge of and expertise with US and worldwide device regulations; must have experience interacting with health authorities
- Experience in the CMC aspects of biopharmaceutical development
- Ability to lead / influence cross-functionally and at a senior level within the organization, including direct experience working with senior leadership teams
- Experience leading external activities and collaborations with medical device technology and pharma partners
- Ability to lead / influence cross-functionally and at a senior level within the organization, including direct experience working with senior leadership teams
- Leadership in implementing new technologies and driving continuous improvement within device development
- Ability to work in a collaborative team environment across multiple technology areas
- Excellent communication skills and strong interpersonal skills
- Demonstrated leadership in mentoring and development of people
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.
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