Device/Combination Product Manager

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a senior leader to direct device and combination product development across its obesity/metabolic portfolio.

You will establish design controls and risk management, oversee external partners, and drive regulatory content for INDs/NDAs while ensuring phase-appropriate deliverables with CMC, Regulatory, and Clinical teams. The role requires deep expertise in drug-device combinations, parenteral systems, and compliance with 21 CFR Part 4 and ISO 13485.

Qualifications

• Hands-on experience developing drug-device combination products from concept through commercialization.
• Knowledge of 21 CFR Part 4, 820, ISO 13485, ISO 14971, IEC 62366-1, ISO 10993.
• Experience establishing design controls, DHF, verification and validation, and usability programs.
• Experience managing external device suppliers, CMOs, and CDMOs with on-time delivery.
• Authoring device sections of regulatory submissions and interacting with health authorities.
• Familiar with parenteral/injectable delivery systems and related cold-chain considerations.

Responsibilities

• Serve as the internal SME and technical lead for device and combination product development.
• Establish and maintain design controls and the Design History File per applicable standards.
• Lead risk management activities per ISO 14971 across the product lifecycle.
• Direct human factors and usability engineering programs including studies and risk analyses.
• Oversee activities at external suppliers, CMOs, and CDMOs including design transfer.
• Author device sections of regulatory submissions and support inquiries from authorities.
• Define device specifications, performance criteria, and testing strategies.
• Partner with CMC, Drug Product, Quality, Regulatory, Clinical, and Supply Chain teams.
• Provide updates and build internal device capability and governance.

Skills

Device development

Regulatory knowledge

Design controls

External partnerships

Regulatory submissions

Parenteral delivery

GLP-1/GIP experience

Communication skills

Project leadership

Education

B.S. in Biomedical Engineering

M.S. in Biomedical Engineering

Job description

Viking Therapeutics is a clinical-stage biotechnology company advancing a next-generation portfolio of therapies for obesity and metabolic disease. We are developing treatments to help patients achieve meaningful, lasting improvements in health by treating obesity first. Our therapies are designed to support the long-term health benefits of weight loss, including cardiovascular health, improved physical function, and quality of life.

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.

Essential Duties and Responsibilities

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.

Requirements

Education and Experience

• 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.

Knowledge and Skills

• Demonstrated hands-on experience developing drug-device combination products (e.g., prefilled syringes, autoinjectors, pen injectors) from concept through commercialization, including design and integration of the device constituent part.
• Working knowledge of combination product and device regulations and standards, including 21 CFR Part 4, 21 CFR 820 (Quality System Regulation), ISO 13485, ISO 14971, IEC 62366-1, and ISO 10993.
• Experience establishing and managing design controls, Design History Files, design verification and validation, and human factors / usability engineering programs.
• Track record of managing external device suppliers, CMOs, and CDMOs, including design transfer, component qualification, and delivery on time and within budget.
• Experience authoring device and combination product sections of regulatory submissions and supporting health authority interactions in collaboration with Regulatory Affairs.
• Experience with parenteral / injectable delivery systems and, ideally, peptide or GLP-1/GIP combination products and associated cold-chain considerations, is a plus.
• Strong written and verbal communication skills; ability to translate technical device matters into clear documentation and regulatory content, and to influence cross-functional and executive stakeholders.
• Entrepreneurial mindset with the ability to thrive in a fast-paced, lean biotech environment; strong organizational skills, attention to detail, and the ability to build internal capability while managing multiple priorities and external partners simultaneously.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.