Device ​/ Combination Product Manager

Description

The Device / Combination Product Manager serves as the internal technical leader and subject-matter expert for medical device and drug-device combination product development across Viking Therapeutics’ pipeline. This role partners closely with internal Chemistry, Manufacturing and Controls (CMC), Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams, as well as with external device suppliers, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs), to plan and execute phase-appropriate device and combination product activities from early development through late-stage clinical and pre-commercial readiness.

The Device / Combination Product Director will establish and oversee design controls, risk management, human factors, and design verification and validation for the device constituent parts of combination products (such as prefilled syringes, autoinjectors, and pen injectors), and will ensure compliance with applicable combination product and device regulations. The role will contribute device and combination product content to CMC documentation and regulatory submissions across Viking’s portfolio, including the company’s lead GLP-1/GIP dual agonist program (VK2735) and additional metabolic and endocrine disorder pipeline assets.

The level of the role will be commensurate with the candidate’s experience and qualifications.

The main responsibilities of this role include:

• Serve as the internal subject-matter expert and technical lead for medical device and combination product development across Viking’s portfolio, including the device constituent parts of drug-device combination products such as prefilled syringes, autoinjectors, and pen injectors.
• Establish and maintain design control processes (per 21 CFR 820.30 and ISO 13485) and the Design History File (DHF), including user needs, design inputs and outputs, design reviews, and design verification and validation.
• Lead device and combination product risk management activities in accordance with ISO 14971, including hazard analysis, design and use FMEAs, and benefit-risk assessment throughout the product lifecycle.
• Direct human factors and usability engineering programs (per IEC 62366-1 and applicable FDA human factors guidance), including formative and summative studies, use-related risk analysis, and instructions for use.
• Oversee device and combination product activities at external suppliers, device CMOs, and CDMOs, including design transfer, component qualification, biocompatibility (ISO 10993), and manufacturing and assembly controls.
• Author and review device and combination product sections of regulatory submissions (INDs, CTAs, NDAs/BLAs) consistent with 21 CFR Part 4 combination product cGMP requirements, and support responses to health authority questions in collaboration with Regulatory Affairs.
• Define device specifications, essential performance requirements, acceptance criteria, and control strategies; support container-closure, extractables and leachables, and device performance testing in partnership with Drug Product and Analytical Development.
• Partner cross-functionally with CMC, Drug Product, Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure integrated, phase-appropriate, on-time combination product deliverables.
• Provide device and combination product updates, risk assessments, and timelines at integrated project team meetings and to executive stakeholders, and help build internal device capability, processes, and governance.
• Other duties as assigned.

• B.S. in Biomedical Engineering, Mechanical Engineering, a related engineering field, or a relevant scientific discipline, with 10+ years of medical device and/or combination product development experience in the pharmaceutical, biotech, or medical device industry; or M.S. with 8+ years; or an equivalent combination of education and experience.
• Title and level (Director vs. Senior Director) will be commensurate with the candidate’s experience and qualifications.

• Demonstr…