QuantuMDx is dedicated to improving and democratising global health by providing transformative diagnostic tools to overburdened healthcare systems.
QuantuMDx VP Product Realisation
VP Product Realisation
- Supports company functional groups with analysis and scientific knowledge, including but not limited to; sales and marketing, project management, business development, general and administrative, IP, quality, regulatory, medical affairs, product transfer, product support and operational diagnostic service groups within the organisation and with collaboration partners, with the ultimate goal to improve patient care by development of innovative, new diagnostic tests.
- Works with the CSO to manage the company’s professional relations with external scientific thought leaders in an effort to advance the organisations position in the marketplace and to identify new diagnostic product opportunities, competitive activity, licensees and emerging technologies.
- Co-ordinates the end user and patient engagement & training teams to ensure they are focused to the needs of the R&D and commercialisation teams and are up to date with the latest information.
- Co-ordinates and manage the clinical trials co-ordination group, guide on trial strategy and implementations. Guide the company’s publication strategy.
- Supports company activities with all applicable regulatory agencies, payers, guideline organisations, and patient advocacy groups, including but not limited to; FDA, CLIA, CAP, CMS, CDC, WHO, OSHA, ILADS, IDSA, CE and ISO.
- Works with the senior management team to undertake long term and short term planning and supervision of commercialisation projects that require interaction with business and manufacturing units. Makes decisions on the work programs and monitors project and program costs. Develops strategies to ensure effective achievement of scientific and business objectives. Develops budgets for capital expenditure, labour and contracts.
- Represents the company as prime internal and customer contact on contracts or operations. Conducts briefing and technical meetings for top management and customer representatives.
- Provides support in attracting and obtaining major new company business.
- The position is based in Newcastle upon Tyne, UK, local and international travel is expected.
- Competitive market rate salary will be offered, dependent on specific experience.
Key Roles & Responsibilities
- Work with the CSO and SAB to develop the company’s clinical implementation strategy including managing the development of clinical trial protocols and the trials themselves
- Implementing and documenting transfer of development projects to the Manufacturing Team
- Provides guidance to the Manufacturing Team in outsourcing of manufacturing in a compliant manner
- Provides guidance to the Quality Team on the design of the company’s quality system
- Provides guidance to the Regulatory Team on the regulatory strategy
- Provides support for the management of outside vendors including selection and contracts
- Perform work in a timely and organised fashion.
- Develop project timelines and manage project completion within those timelines.
- Develop and support an atmosphere for a teamwork environment and professional conduct.
- Develop methods of measurement to allow for the objective benchmarking to improve quality of technology transfer, product realisation, regulatory requirements fulfilment, product registration
- Plans schedules and budgets as required
- Works internally to plan, design and setup product support activities
- Liaison with external scientific collaborators as required
- Assures alignment of commercialisation and financial goals
- Assures transfer of necessary information to regulatory affairs/medical affairs/marketing, and other company functional groups
- Acts as an internal consultant as needed to answer questions and educating staff as required
- Clear communication at all levels of the organisation internally (from an entry level bench Technician, to the Board of Directors as requested) and externally with collaborators at all levels of scientific understanding (from academic peers, to non-technical investors, patients, or other stakeholders)
- Guarantee scientific quality, integrity and knowledge within the organisation
Experience, knowledge and requirements
- Strong software/PC skills (Word, Excel, Microsoft Project)
- Progressive experience in a Research and Development environment
- Good organisation skills
- Strong written and communication skills
- PhD in a relevant scientific discipline with 10+ years-experience in in vitro diagnostics
- Hands-on experience in commercialisation with various diagnostic technologies with a focus on developing new diagnostic tools for urgent clinical needs
- Experience in clinical study design / management, bioinformatics, statistical analysis, data interpretation, algorithm development, new technology platforms
- Experience in grant applications, patent applications/prosecution, marketing and regulatory affairs
- Successful collaboration with academic, medical and business partners and international network with academic groups within the diagnostic industry
- Experience in commercialisation in both Low to Middle Income and High Income Countries
- Good sense of humour
The intent of this job description is to provide a representation and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
QuantuMDx Group is one of the most exciting life sciences, tools and technology companies to emerge from the UK in recent years. Due for commercialisation in 2018, their signature device Q-POC™ is a low-cost, simple-to-use, handheld diagnostic device for 10 – 20 minute diagnosis at the patient’s side. The robust device will identify the presence and strain of an infection, ensuring the right drug is prescribed first time, facilitating a more intelligent use of antibiotics.
Further to this, globally distributed Q-POC™ devices will geotag and anonymise pathogen data, sending it to the cloud for real-time disease and drug resistance monitoring, and rapid detection and containment of pathogens.
Q-POC™ is ideally suited to help address the humanitarian health burden by offering goldstandard molecular diagnostics at a fraction of the cost of traditional testing. Once the device has passed regulatory approval it will be available for highly multiplexed diagnostic and drug susceptibility testing from just a few dollars, in any setting globally.