Device Lead, Technology and Innovation

Role Summary

The Device Lead, Technology and Innovation will serve an important role in developing, networking, and executing our strategies that expand and advance the company’s ability to deliver innovative, robust and competitive technologies in drug delivery and combination products across GSK’s asset pipelines and portfolio. The ideal candidate shall possess deep knowledge of device technology landscape, technical design/development regimen, and innovative and risk-taking minds. This role sits in the Device Technology and Innovation group and offers growth, visible impact on patient-centric solutions, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities

• Monitor and analyze external market trends, competitive landscape, and emerging technologies to ensure access to cutting edge drug delivery technologies which are strategic to delivery GSK pipeline.
• Lead specific pipeline asset-based device technology exploration, assessment, and feasibility studies while engaging with Early Engagement and Device-ability, Device Engineering, Primary Packaging, Formulation and Patient Insight Subject Matter Experts (SMEs).
• Define and deliver technology development plans, including scope, schedule, budget and milestones.
• Coordinate cross-functional teams and external partners to progress design, prototyping, testing and manufacturability assessments.
• Identify technical risks and lead mitigation activities using test programs, simulation, technical deep dive, and project and functional governance reviews.
• Communicate results and recommendations clearly to stakeholders and senior leadership.
• Manage a network of external technologic partners and engineering vendors to help accelerate innovation and both build and expand GSK’s drug delivery device capability.
• Help drive an internal culture of innovation, including developing and curating a portfolio of problem statements across the portfolio, leading structured ideation sessions, and encouraging creativity.

Qualifications

• Required: Bachelor’s degree in Mechanical, Biomedical, Chemical Engineering or a related technical field.
• Required: 10 or more years of relevant industry experience in medical device drug-device combination development.
• Required: Experience with parenteral delivery devices such as pre-filled syringes, autoinjectors, and on-body injectors.
• Required: Experience leading technology assessments, feasibility studies, or early-stage device programs.
• Required: Experience with design and development of medical device from early concept to launch phases, preferably in the drug delivery space.
• Required: Experience with regulatory requirements for parenteral or respiratory combination products (21 CFR Part 4 & 820, ISO 13485, 14971 & IEC 62366).
• Required: Experience working with external partners, suppliers or contract manufacturers.
• Required: Experience with regulatory requirements for combination products and medical devices.
• Preferred: Advanced degree (master’s or PhD) in an engineering or related discipline with a minimum of 5 years of relevant industry experience.
• Preferred: Strong collaboration and communication skills, with experience working in cross-functional teams.
• Preferred: Experience with respiratory delivery devices such as Nebulizers and inhalers such as pMDI, DPI and soft mist inhalers.
• Preferred: Self-motivated and organized, knowledgeable of relevant scientific literatures, patient-focused, creative, open-minded, highly motivated results-oriented and have high learning agility.
• Preferred: Both technically strong and possess strong business acumen, with a proven track record in the successful innovation, development and commercialization of combination devices from both a technical and strategic perspective.
• Preferred: Strong verbal, written, and interpersonal communication skills, with ability to lead through matrix team and influence decisions at all levels.