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The Position

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

The Opportunity:

This role is seated in the Clinical Validation subchapter within the Digital Technology Health Information (DTHI) function for Roche Information Solutions (RIS). We are seeking an experienced clinical and scientific leader to spearhead evidence-generation activities for cutting-edge digital health solutions. With a primary focus on regulated AI algorithms (including medical Imaging AI solutions) and groundbreaking digital biomarkers (such as those used for Clinical Decision Support or Clinical Trials) this position offers an unparalleled opportunity to shape the future of healthcare innovation. Join us and be at the forefront of transforming clinical practice through state-of-the-art technology!

Your main responsibilities include:

• You provide senior-level expertise and clinical evidence to support regulatory submissions and interactions (e.g. FDA EMA).

• You represent the organization as an expert in clinical validation during meetings with regulatory authorities.

• You work in close contact with regulators and notified bodies.

• You provide expert guidance on study design methodologies and study endpoints to ensure robust and regulatory-compliant clinical evidence generation.

• You lead the improvement of the evidence generation process for AI solutions spanning from early development to post-market phases (incl. drafting GSPs guidance documents SoPs).

• You serve as a mentor and thought leader within the organization fostering the development of evidence leads/managers.

• You coordinate and lead the development of integrated evidence plans for assigned digital health solutions with specific reference to the clinical validation ofSoftware as Medical Device (SaMD).

• You coordinate and drive the execution of studies for assigned digital health solutions.

• You work in close contact with the clinical experts and external researchers to support evidence generation for assigned digital health solutions.

• You develop and provide metrics on upcoming and ongoing studies ensure that team members follow up on crucial deliverables and conduct timely data analysis of study results.

• You lead and support stakeholders to create evidence outputs such as white papers case studies abstracts and/or full manuscripts and present research findings at scientific conferences and via other communication channels.

• You lead and support stakeholders in completing the technical file for assigned digital health solutions classified as SaMD.

• You guide thought leadership activities and champion innovative methodologies within Roche and the wider academic community to advance the field of evidence generation for digital health products.

• Your work with partners should be knowledgeable responsive and provide an outstanding experience.

• You are comfortable working in a fast-paced agile environment and ready to apply an AI first mindset.

• Finally you will contribute to the establishment & development of a center of excellence for evidence generation for digital health solutions.

Who are you

• A minimum of 12 years of related experience with a Bachelors degree;

• or 8 years and a Masters degree;

• or a PhD with 5 years of experience; or equivalent experience.

Needed Skills and Qualifications:

• Proficient English skills; excellent communication and collaboration skills as well as phenomenal (project) leadership & management skills

• Proven experience in medical & scientific affairs in industry or academic setting (Medical Device Industry preferred)

• Good understanding of the evidence needs for SaMDs

• Extensive experience in evidence generation for medical AI models/algorithms

• Previous end to end experience with successful submissions and regulatory approvals for AI algorithms (desired)

• Additional experience in radiomics / imaging AI models (desired)

• Excellent understanding of research methodologies data analysis and scientific communication (writing & presenting)

• Experience in clinical operations and/or clinical data management in the health & life sciences industry

• Clinical background preferred

Locations:

You are local to Indianapolis IN

*Relocation benefits are available for this position.

The expected salary range for this position based on the primary location of Indianapolis IN is between $131100 and $243500. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.