IVD Domain Expert

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The Position

We are seeking an experienced and innovative digital Application Specialist in the In Vitro Diagnostics (IVD) domain to join our dynamic Data, Analytics, and Research team. This role involves working closely with data scientists, data engineers, and data quality engineers to develop advanced analytics products within the IVD space.

As a Clinical Application Specialist, your responsibilities will include providing clinical expertise to support the development and implementation of data-driven solutions, acting as a bridge between clinical practice and data analytics, and ensuring that our products meet the highest standards of clinical validity, operational excellence, and utility. You will play a critical role in translating clinical needs into technical requirements and collaborating with cross-functional teams to deliver impactful solutions.

This position offers a unique opportunity to contribute to cutting-edge analytics and digital products in the healthcare sector and drive innovation in digital diagnostic solutions.

KEY RESPONSIBILITIES 

• Provide clinical expertise and insights to guide the development of analytics products in the IVD domain.

• Collaborate with data scientists, data engineers, and data quality engineers to ensure clinical relevance and accuracy of analytics solutions.

• Translate clinical requirements into technical specifications and work with the development team to implement these requirements.

• Support the validation and verification of analytics products to ensure they meet clinical standards and regulatory requirements.

• Conduct training sessions and workshops to educate internal teams on clinical & operational aspects of IVD products and their application.

• Serve as the primary point of contact for IVD domain-related questions and provide domain-specific support to internal teams and external customers.

• Stay updated with the latest advancements in the IVD domain and incorporate relevant findings into product development.

• Facilitate communication between laboratory & business stakeholders and technical teams to ensure seamless integration of clinical insights into product development.

• Drive innovation by identifying new opportunities for advanced analytics and proposing solutions to address unmet business needs.

• Contribute to the development of clinical documentation, including user manuals, validation reports, and regulatory submissions.

REQUIRED EXPERIENCE, SKILLS & QUALIFICATIONS 

• A minimum of 8-10 years of experience in the diagnostics field, with at least 4+ years of direct involvement in IVD.

• Strong understanding of diagnostics laboratory workflow and practices, diagnostic assays, and regulatory requirements in the IVD domain.

• Proven experience in working with data analytics and familiarity with data-driven decision-making processes in a clinical context.

• Ability to translate clinical needs into technical specifications and effectively communicate these requirements to technical teams.

• Excellent problem-solving skills and the ability to conduct root cause analysis to address clinical and technical issues.

• Strong interpersonal and communication skills, with the ability to explain complex clinical concepts to non-clinical stakeholders.

• Demonstrated ability to work collaboratively with cross-functional teams in a fast-paced and dynamic environment.

• Familiarity with relevant software and tools used in data analytics and diagnostics (e.g., LIS, HIS, middleware, statistical analysis software).

DESIRED EXPERIENCE, SKILLS & QUALIFICATIONS 

• Advanced degree (Master’s or Ph.D.) in a relevant scientific field (e.g., Medical Technology, Clinical Laboratory Science, Biology, Chemistry).

• Hands-on field experience in the IVD lab domain.  

• Experience with advanced analytics and machine learning applications in the healthcare domain.

• Knowledge of regulatory processes and requirements for IVD products.

• Experience in product development and lifecycle management in the diagnostics industry.

• Ability to stay abreast of new developments and innovations in the IVD field and apply this knowledge to drive product innovation.

EDUCATION 

Master’s degree/Bachelor’s degree in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, Pharma, or a related field.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.