Executive Director, Device Product Platforms

Role Overview

• Lead and inspire the Device Product Platforms (DPP) organization, including driving Platform Leadership for Auto Injectors (for multiple therapeutic areas), Prefilled Syringes for Vaccines, Prefilled Syringes for Intravitreal Injections, Combination Product Kits, and Inhalation Devices.
• Develop and implement strategic initiatives to advance a platform-based approach to deliver the portfolio that is device and combination products enabled, ensuring integration across internal and external functional teams and alignment with DD&T and enterprise objectives.
• Retain and develop top technical talent, promote skills and expertise, and foster a culture of scientific and technical excellence.
• Provide expert guidance on the design, development, and evaluation of device products, components, materials, packaging systems, and manufacturing processes.
• Oversee verification strategies, material properties assessments, design assessments; leverage data analysis and risk-based approaches aligned with best-in-class combination product development and commercialization.
• Drive innovation and continuous improvement in product quality and process efficiency.
• Oversee the Drug Device Combination Products portfolio across all therapeutic areas, modalities, and platforms for our company's molecule portfolio that is device and combination products enabled.
• Ensure robust platform expertise in prefilled syringes for vaccines (1 mL, 2.25 mL, 5.5 mL), auto injectors, pen injectors, combination product kits, prefilled syringes for intravitreal injections, inhalation devices, and other nasal delivery mechanisms.
• Support the evolution of the organization by identifying and developing future platform leaders as the pipeline needs evolve.
• Collaborate with stakeholders across Research, Clinical, Regulatory, Quality, and Manufacturing to ensure seamless product development and commercialization.
• Ensure compliance with regulatory requirements and industry standards for combination products and medical devices. Identify and mitigate technical and operational risks across the product lifecycle working with cross-functional teams across the enterprise.

Requirements

• Minimum 15 years of progressive engineering leadership experience in device or combination product development within the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated experience with device and combination products in at least three of the following therapeutic areas (preferably with marketed products): Cardiometabolic, Infectious Disease, Ophthalmology, Immunology, Oncology, Neuroscience.
• Proven track record in at least five of the following device categories (preferably with marketed products): Prefilled Syringes for vaccines; Intravitreal Prefilled Syringes for eye injections; Prefilled Syringe needle safety devices; 1 mL Auto Injectors; 2 mL Auto Injectors; >2.25 mL Auto Injectors; Pen Injectors; Combination Product Kits; Dry Powdered Inhalers; other Nasal Delivery mechanisms.
• Strong ability to lead scientific and technical teams, drive organizational change, and influence at all levels of the organization.
• Provides timely feedback and coaching to talent across the new product development and commercialization business areas.
• Applies a deep understanding of new product development and commercialization business, inclusive of external landscape, to shape strategy.
• Demonstrates understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and human health, balancing the needs of patients and ensuring successful launch and stable supply of product.

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days