Associate Director, Drug-Device Concept & Delivery

GlaxoSmithKline; Waltham (MA); Hybrid; USD 143,000 - 238,000; Full time

Benefits offered by this job

Health care and other insurance

Retirement benefits

Paid holidays and vacation

Paid caregiver/parental and medicalle

Annual bonus

Job summary

GlaxoSmithKline seeks an Associate Director to lead the design and development of drug-device combination products within the Packaging, Device and Design Solutions team. You will integrate technical attributes with patient needs, business requirements, and regulatory expectations across modalities.

You will collaborate with Discovery, Clinical, Quality, Regulatory and Manufacturing Science to drive design controls, verification, validation and technology transfer, ensuring robust development

Qualifications

• Bachelor's degree in engineering, materials science, pharmaceutics or related technical discipline.
• 8+ years of experience in design and/or development of medical devices or drug-device combination products.
• Experience with design controls, risk management, design history file requirements.
• Experience working with suppliers, contract manufacturers or external technology partners.

Responsibilities

• Collaborate with internal teams to develop on‑target patient‑centric DDC products and ensure integrated product development.
• Systematically engage and influence early to understand the technical requirements, outline investments, tradeoffs and risks for the portfolio.
• Identify technical risks, lead mitigation using testing and modelling to support device selection.
• Plan and execute engineering studies, device characterization, design verification and validation.
• Author and review key technical documentation and regulatory submission.
• Support industrialization and technology transfer of devices to manufacturing sites, including process development support and design for manufacturability.
• Monitor industry trends and collaborate with academia, government organizations and professional consortia associated with DDC products.

Skills

CMC Strategy

Data-Driven Decision Making

Data Integrity

Debate Moderation

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Process Optimization

Project Leadership

Risk Awareness

Scientific Writing

Technology Transfer

Education

Bachelor's degree in engineering or related technical discipline

Advanced degree (Master's or PhD) in engineering or related field

Job description

GlaxoSmithKline seeks an Associate Director to lead the design and development of drug-device combination products within the Packaging, Device and Design Solutions team. You will integrate technical attributes with patient needs, business requirements, and regulatory expectations across modalities.

You will collaborate with Discovery, Clinical, Quality, Regulatory and Manufacturing Science to drive design controls, verification, validation and technology transfer, ensuring robust development