Associate Director – Concept Development and Delivery

GSK

. Integrate technical attributes, patient and user needs, business requirements, competitive landscape and technologies for drug-device combination products .

Posted 9/21/2026full-timeUnited StatesSenior💰 $142,725 - $237,875 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in the design and development of drug-device combination products, with a strong focus on regulatory compliance, risk management, and cross-functional collaboration. Proficient in technical documentation, process optimization, and leading engineering studies to ensure successful product integration and industrialization.

Highest-signal resume keywords

Drug-Device Combination Product DevelopmentRegulatory Compliance (21 CFR QSR, ISO 13485, ISO 14971)Design Controls and Risk ManagementSimulation and Statistical AnalysisCross-Functional Team Collaboration

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Design ControlsRisk ManagementTechnical DocumentationProcess OptimizationDevice CharacterizationDesign Verification and ValidationSimulation and ModelingStatistical AnalysisHuman Factors EngineeringUsability Testing

Soft Skills

Time ManagementOrganizational SkillsCommunication SkillsInfluencing Without AuthorityTechnical Writing

Tools & Technologies

Prefilled SyringesAutoinjectorsOn-Body InjectorsNon-Integral Co-Pack Combination ProductsLean ManagementGxP Regulations

Industry Keywords

Medical DevicesPharmaceuticsBiologicsSmall MoleculesVaccinesTechnology TransferManufacturing Science and Technology

About the role

Key responsibilities & impact

Integrate technical attributes, patient and user needs, business requirements, competitive landscape and technologies for drug-device combination products
Support development efforts to improve the probability of technical success of development programs
Collaborate with Discovery, Clinical, Commercial, Quality, Manufacturing Science and Technology, Regulatory and Drug Product Development teams
Develop on-target, patient-centric drug-device combination products and ensure integrated product development
Engage early to understand technical requirements and challenges, develop product concepts, and outline investment requirements, tradeoffs and risks
Identify technical risks and 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 submissions
Support industrialization and technology transfer of devices to manufacturing sites
Provide process development support, design for manufacturability and resolution of device-related challenges
Monitor industry trends and collaborate with academia, government organizations and professional consortiums associated with drug-device combination products

Requirements

What you’ll need

Bachelor’s degree in engineering, materials science, pharmaceutics or a 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, and design history file requirements
Experience working with suppliers, contract manufacturers or external technology partners
Advanced degree in engineering or a related field preferred
Experience with parenteral delivery systems such as prefilled syringes, autoinjectors, on-body injectors and non-integral co-pack combination products preferred
Experience across multiple modalities including large molecules/biologics, small molecules and vaccines preferred
Experience with relevant regulatory and quality frameworks, including 21 CFR QSR, ISO 13485 and ISO 14971 or equivalent, preferred
Experience with simulation, modeling and statistical analysis for design evaluation preferred
Experience supporting human factors engineering and usability testing preferred
Ability to work in cross-functional, global teams and communicate complex technical topics clearly to non-experts and management
Strong time management and organizational skills, with ability to support multiple projects of varying complexity simultaneously
Ability to work in a complex matrix environment and influence and lead others without hierarchical authority
Strong oral and technical writing skills, with experience preparing protocols, reports and/or design documentation
Skills including 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 and Technology Transfer

Benefits

Comp & perks

Annual bonus
Eligibility to participate in share-based long-term incentive program
Health care and other insurance benefits for employee and family
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Hybrid work arrangement
Occasional travel opportunities to suppliers or other sites