Director, Medical Affairs; Pathology​/Oncology

Director, Medical Affairs (Pathology/Oncology) page is loaded## Director, Medical Affairs (Pathology/Oncology) locations:
US - California - San Diego:
US - California - Southern - Remote time type:
Full time posted on:
Posted Yesterday job requisition :
42236-JOB## At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.## Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference.

Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.##
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* Position Summary:

** Illumina, Inc. is seeking a medical professional with board certification in molecular pathology with a strong background in cancer diagnostics, biomarkers, cancer therapeutics and extensive experience in developing genomic tests for Oncology.

This position is within Illumina’s Medical Affairs organization. This role will be responsible for actively contributing to product development in Illumina’s R&D organization, conducting patient safety risk assessments for Regulatory and Quality teams, supporting product submissions for regulatory approvals, companion diagnostics development for pharma collaborations, and participating in medical education on molecular screening and diagnostics for cancer and hereditary diseases. The individual in this role will represent Medical Affairs within cross-functional teams focused on developing Illumina’s instruments, assays, or software for disease screening and diagnostics and, as necessary, work closely with Commercial, Business Development, Pharma, R&D, Product Marketing, Regulatory, Software and Informatics, Assay Development, and Quality teams.

The ideal candidate has held leadership positions in clinical genomics laboratories utilizing advanced next-generation sequencing technologies (NGS). This individual has a strong background in the development and application of molecular an conventional diagnostics methods used for cancer screening and diagnostics as well as hereditary diseases. Understanding of diagnostic approaches in genetic disease testing are required, including karyotyping, FISH, MSI analysis, and NGS.

In addition, this individual must have excellent understanding of variant classification and reporting standards and the relevance of tertiary analysis software for these purposes. The candidate must be aware of trends in professional practice in molecular diagnostics in the United States and beyond as well as a wide network of connections with key opinion leaders and professional societies. The candidate must have demonstrably intimate understanding of the trends in next-generation sequencing, clinical laboratory practices and their regulatory oversight, and technologies broadly deployed in clinical laboratories for molecular screening and diagnostics in cancer and hereditary diseases.

The candidate must have demonstrated active participation in research and publications that have contributed to advancing genomics in medicine

This role will also provide direct medical affairs support of pharma partnerships as well as lead the development and execution of an external facing molecular diagnostic tumor board
** Scope of Responsibilities:
*** Actively participate in the product development process in R&D to guide specifications for Illumina’s RUO and IVD products. Work closely with Marketing, Product Marketing, Assay/Product Development as well as product life cycle teams to support the execution of the product launch strategy, and ensure internal and external launch readiness
* Coordinate medical affairs strategies for evidence generation and scientific communication in relation to product development and product launches across cancer screening and diagnostics and hereditary diseases
* Collaborate with Market Access to strategize and develop the necessary evidence to improve…