Director, Medical Device & Combination Products

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Device / Combination Product Director to lead medical device and drug-device development across our pipeline.

You will collaborate with CMC, Drug Product, Regulatory Affairs, Quality, and external partners to plan phase-appropriate activities from development through pre-commercial readiness. The role requires establishing design controls, risk management, and usability engineering in line with 21 CFR and ISO standards, and preparing regulatory submissions.

Qualifications

• BS in Biomedical Engineering or related field with 10+ years of device or combination product experience.
• MS with 8+ years of relevant experience, or equivalent education/experience.
• Title level (Director vs. Senior Director) determined by experience.

Responsibilities

• Serve as internal SME and technical lead for medical device and combination product development.
• Establish and maintain design controls and DHF per 21 CFR 820.30 and ISO 13485.
• Lead device risk management per ISO 14971, including FMEAs and risk assessments.
• Direct human factors programs per IEC 62366-1 and FDA guidance.
• Oversee activities with external suppliers, CMOs, and CDMOs.
• Author and review regulatory submissions with Regulatory Affairs.
• Define device specifications, acceptance criteria, and testing plans.
• Partner cross-functionally to ensure on-time deliverables.
• Provide updates and build internal device capability and governance.
• Other duties as assigned.

Skills

Design controls

Regulatory submissions

External partner mgmt

Human factors

Device regulations

Parenteral delivery systems

Cross-functional collaboration

Regulatory affairs collaboration

Education

BS in Biomedical Engineering or related

MS in Biomedical Engineering or related

Job description

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.

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.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

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.

Salary Description

$110,000.00 - $135,000.00 annual salary