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Senior Officer, Product Development

Organization

FIND, Foundation for Innovative New Diagnostics

Job Location

Chemin des Mines 9
1202 Geneva
Switzerland

Job Description

Organization: FIND, the global alliance for diagnostics, seeks to ensure equitable access to reliable diagnosis around the world. We connect countries and communities, funders, decision-makers, healthcare providers and developers to spur diagnostic innovation and make testing an integral part of sustainable, resilient health systems. We are working to save 1 million lives through accessible, quality diagnosis, and save US$1 billion in healthcare costs to patients and health systems. We are co-convener of the Access to COVID-19 Tools (ACT) Accelerator diagnostics pillar, and a WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. Location: FIND Headquarters in Geneva OR FIND Country offices in either South Africa, Kenya, India or Viet Nam Reporting to: Deputy Director, Technology Innovation Term : Permanent role Background: This position will be part of FIND Technology & Development department. Led by FIND Chief Technology Officer, Technology & Development is a cross-cutting department within FIND matrix structure supporting the product development process from pre-concept through launch across all of FIND Disease Programmes (currently including Antimicrobial Resistance, Hepatitis, Malaria & Fever, Neglected Tropical Diseases, Non-Communicable Diseases, Pandemic Threats, Tuberculosis, and Women’s Health). In addition to core staff with expertise in Product Development and in Manufacturing, the Technology & Development department hosts the cross-cutting platforms teams in Digital Health and Genomics & Sequencing, the Data Science unit, as well as expertise in assessing diagnostic technologies in the Business Intelligence unit. This role requires up to 25% travel POSITION SUMMARY: Your mission This is a senior position at FIND at the level of Senior Officer or Principal Officer, responsible for the technical leadership and coordination of all product development activities within FIND’s matrixed environment. As a product development partnership, FIND does not conduct product development activities in-house; rather, FIND partners with in vitro diagnostics (IVD) manufacturers to support the development, launch, and commercialization of products. As such, the successful candidate will represent the Technology & Development department across a portfolio of FIND’s partnerships with industry. The successful candidate will be the main point of contact on product development issues for the broad portfolio of R&D activities conducted across FIND’s disease programmes. This position will serve largely as an internal resource, providing technical advice and leadership during project planning and execution, as well as coordinating a small team of consultants and FIND officers to support FIND product development projects, ensuring adequate resource allocation. Your responsibilities The specific activities will include, but not be limited to: • Develop, implement, and maintain a framework to guide all product development activities at FIND, based on industry standards for phase-gated IVD product development • Work with FIND Disease Programmes to provide expert support to FIND project teams and to partners from the IVD industry. This includes, but is not limited to, providing guidance, review, and feedback on product requirements, product development strategy, design and development plans, timelines, risk assessments, and other design input and output documents; providing guidance, review and feedback on the design of proof-of-concept and analytical studies; providing technical support in the selection and development of key reagents and materials, as well as required sample preparation steps; and providing support in data analysis and interpretation • Work with the Technology & Development Portfolio Manager to recognize synergies and inter-dependencies between projects across FIND • Work with FIND Medical Affairs team to review the design of rigorous validation and other clinical studies that meet international standards and target product requirements for those products in FIND product development portfolio • Support the FIND Access and Impact teams, on an as-needed basis, by providing technical information relevant to the development of pilot and scale-up access programs, strategies to deliver impact on health outcomes and/or effective and efficient health service delivery for those products in FIND product development portfolio The above activities will be accomplished by a combination of direct contributions and managing a small team of consultants and FIND internal resources. • Participate in regular teleconferences and perform on-site visits to industry partners • Be an internal resource and advisor for FIND program staff in the area of compliant IVD design, development, and manufacturing, as required • Work with FIND Medical Affairs and Business Development teams to develop, implement, and maintain a framework and guidance to conduct due diligence on IVD manufacturers to support technology and partner selection • Conduct partner assessments, due diligence, and technology selection, either directly or by managing an external contractor, as required • Attend and represent FIND at webinars, conferences, and other meetings to initiate or strengthen industry partnerships • Support the publication of peer-reviewed articles, reports, and presentations • Contribute to fundraising activities by providing direct support to proposal and report writing

Requirements

EXPERIENCE/SKILLS REQUIRED: Required qualifications: • Advanced degree (MS or PhD), with at least 10 years of experience in IVD product development in a regulated environment (ISO 13485, 21CFR Part 820) • Successful experience developing assays and/or platforms for use in IVD diagnostic products, from feasibility through development, to transfer to manufacturing, and launch • Solid understanding of the phase-gated product development process, including the appropriate design inputs and outputs, and of quality management systems in the IVD industry • Solid understanding of molecular and/or immunoassay diagnostics • Experience in IVD product regulatory processes, including country-specific product registration requirements highly desired • Experience in some aspects of business development, such as the conduct of partner assessments and due diligence desired • Good understanding of infectious diseases and diagnostic needs in a public health context in low- and middle-income countries (LMICs) preferred • Passionate about improving the quality of life of people living in LMICs • Outstanding analytical and organizational skills and ability to set clear priorities • Excellent communication and interpersonal skills • Ability to work independently and flexibly in a resource-limited environment • Team player comfortable working in a multi-cultural environment • Experience working in a matrix structure a plus • Fluent in verbal and written English; other languages are a strong advantage To apply Please send your application by 1 July 2022 Please note that due to high volume of applications, ONLY short-listed candidates will be contacted. FIND is dedicated to building an inclusive workforce where diversity is valued. FIND is an equal opportunity employer. Every qualified applicant will be considered for employment. FIND does not discriminate based on race, colour, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, pregnancy, disability status, political ideology, military status, or any other attribute protected by applicable law.