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Vice President of Drug-Device Combination Product Development

Vice President of Drug-Device Combination Product Development

Vaxess is an NIH and venture-funded company developing a pipeline of next-generation vaccines on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables weeks of sustained delivery in the skin. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.  

Drug-device combination product development at Vaxess is cross-disciplinary, integrating mechanical engineering, biomedical engineering, chemical engineering, biomaterials, chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated individual with a proven track record in medical device development to lead our team of engineers, scientists, and human factors experts. This role offers a unique opportunity to take Vaxess through initial clinical trials, a monumental step in bringing innovative technology to the global vaccine market, while also leading long-term platform strategy.                                                 

Responsibilities 

  • Work under the Chief Development Officer to manage a team responsible for the design, development, and manufacturing of the MIMIX device. 
  • Oversee combination product development in support of pre-clinical and clinical studies. Develop detailed timelines and resource needs to ensure company goals are achieved. 
  • Determine long-term MIMIX platform development strategy to ensure the company is maximizing platform value.                    
  • Serve as subject matter expert in drug-device combination product development. 
  • Work closely with the multidisciplinary Vaxess team and external consultants with specialties spanning Human Factors, Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory.                             
  • Accountable for selecting and managing outside vendors in injection molding, die cutting, 3d printing, sterilization, and off-the-shelf components suppliers to deliver work in a timely manner. 
  • Accountable for leading a team to generate all required documents to support device related components of design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4). 
  • Develop test methods, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc. in line with ISO 14971 Risk Management. 
  • Conduct activities within a quality management system following 21CFR820 Quality System Regulation. 
  • Communicate highly complex ideas and projects to internal executive team, board, and external stakeholders. 
  • Play a critical role in write-up of regulatory filing and answering regulatory questions. Participate in face-to-face meetings with regulatory agencies. 
  •  Manage, train, supervise, and mentor team members. 
  •  Identify and update critical assumptions, quickly escalate risks to the executive team, and pivot activities as strategy is adjusted.

Qualifications 

  • BS in Engineering, or a related discipline, with at least 10 years of direct experience leading the development of medical devices, ideally drug-device combination products. 
  • Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.                           
  •  Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
  • Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
  • Collaborative problem solving, risk assessment, and risk management skills.                             
  • Proven time and project management skills and proven ability to provide accurate timeline estimates and then meet goals and deadlines.
  • Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.
  • Commitment to Entrepreneurial spirit and drive to positively impact global human health.

Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment.                         

Vaxess aims to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status. 

If you’re interested in joining the Vaxess team, please submit your CV/resume to careers@vaxess.com.

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