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VACANCY: Technical Lead / Product Owner for a clinical diagnostic software

technical lead clinical diagnostic software

Technical Lead / Product Owner for a clinical diagnostic software (SaMD / IVD)

Technical Lead / Product Owner for a clinical diagnostic software (SaMD / IVD)

About Scailyte

Scailyte is a globally recognized spin-off from ETH Zürich and pioneer in the field of single-cell data analysis (Nature Spinoff Award, Forbes Top30 in AI, Masschallenge winner, Swiss Top100 Startups). Scailyte’s mission is to discover and develop biomarkers for precision medicine using single-cell data and Artificial Intelligence. Our pioneering technology integrates multimodal single-cell and clinical data to identify novel disease signatures. We are providing innovative solutions for rapid discovery of ultra-sensitive biomarkers for customers in pharma, biotech and clinical research. We are a multidisciplinary multinational team of highly skilled and enthusiastic professionals, offering an inspiring and open-minded environment for career growth. Check out our company video and what our employees say about working at Scailyte: Scailyte Youtube channel

About the Job:

We have applied our unique biomarker discovery approach to address a major unmet need for patients suffering from one of the most prevalent diseases in women – endometriosis. More than 100 million women suffer from this disease globally, and it is a leading cause for infertility and pelvic pain in women. Currently, it takes on average 7 years from initial symptoms to the actual diagnosis of endometriosis and the only available diagnostic method is surgery (laparoscopy). We are on a mission to enable early and accurate diagnostics of endometriosis by developing and commercializing a non-invasive molecular diagnostic test.

As a Technical Lead /Product Owner, you will be leading the translation of our biomarker and algorithms into software for clinical use. To succeed, you will develop a deep understanding of the user and regulatory requirements, working with customers and advisors/consultants of the company, and based on this understanding you will guide a team of data scientists and software developers to create a safe, reliable and high-quality diagnostic product, which will pass clinical validation, receive the approval of regulatory authorities (FDA), and ultimately serve clinicians to improve the lives of millions of patients. You will become the owner of this product end-to-end within the company and toward external stakeholders.

Key responsibilities:

  • Overall accountability for the technical success of our endometriosis diagnostics software product
  • Lead the design, development, and integration of the software product in collaboration with internal and external associates and partners
  • Communicate with key stakeholders, gain an understanding of their requirements and needs
  • Definе and fulfill product development milestones and timelines, focusing the team on priorities to meet the timelines
  • Involve company leadership and critical stakeholders to manage product scope and facilitate tradeoff decisions on functionality in accordance with commercial and regulatory requirements
  • Work closely with other functions (clinical and R&D, regulatory, quality, business development, financial) and drive initiatives to catalyze business growth beyond your core area of responsibility
  • Represent the company and product at conferences in the US and internationally (readiness to travel internationally)

Required skills and experience:

  • 5+ years of experience in Software Development/SaMD projects ideally using design controls
  • Strong knowledge in applicable medical device regulatory requirements (i.p. ISO 13485, IEC 62304, IEC 82304, IEC 62366-1, ISO 14971)
  • Strong communication skills, self-starter, team player
  • Convey complex technical concepts in a clear and actionable way
  • Ability to work in an interdisciplinary environment with a geographically distributed team
  • Excellent written and spoken English
  • Ideally experience with the development of cloud-based software
  • Ideally track record of launching a software product including post market activities
  • Ideally exposure to FDA either in audits or in submissions

What we offer:

  • An exciting opportunity to lead the development of a revolutionary, first-in-class, clinical product that will change the lives of millions of patients suffering from endometriosis
  • Work in a collaborative, multi-disciplinary, and international team at the interface of data science, software development and medicine
  • Permanent employment contract & competitive compensation package including participation in the company’s stock option plan
  • Place of work – Basel, Boston or New York
    • Basel location: we offer a pleasant working environment with great facilities at our office on the Novartis Campus in Basel. For a Switzerland-based position, we will only consider candidates with a valid Swiss work permit or EU/Swiss citizens.
    • Boston / New York – we have offices at the Swissnex hub in Boston and plan to open an office in New York to run our US operations. For a US-based position, we will only consider candidates with a valid Green Card or US citizens.

Application:

Please send your application, including your cover letter and your CV (in English) to careers@scailyte.com.

Call for applications open until May 31st, 2022
Starting date: September 2022

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