What if the work you did every day could impact the lives of people you know? Or all of humanity?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.The Director of Medical Affairs / Medical Lead at Illumina, Inc. provides strategic and functional leadership on the clinical development strategy for new product development and works to define the clinical requirements for diagnostic markers, with a primary focus in Oncology/Companion Diagnostics. S/he will be involved in the research and development planning for diagnostic and prognostic tests and has the opportunity to create medical value for better patient care. The incumbent will lead activities to facilitate and ensure that Illumina leadership is aware of the opportunities in Oncology/Companion Diagnostics, the competitive development landscape, and the current approaches to diagnosis, prognosis, and treatment for Oncology clinical indications. This role will also help driving Illumina’s objectives on integrating the adoption of sequencing technologies and comprehensive genomic insights into clinical practice guidelines, precision medicine treatment pathways, and patient care management in oncology. The Director/Medical Lead will work cross-functionally within Illumina, Inc., as well as with other Illumina entities and also externally with other companies, academic/research centers and pharmaceutics involved in developing cutting edge precision medicine solutions. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, professional and public health organizations, key opinion leaders, advisory boards, etc. This position will be based out of Southern California or remote, reporting to the Global Oncology lead of Medical Affairs. This position will not have direct reports.Key Responsibilities:Serves as a medical leader at Illumina, keeping the company abreast of medical advances in the diagnosis and management of patient care in Oncology.Responsible for providing medical expertise and leadership to the Clinical Affairs, BioStats, Regulatory, Quality, Research, Development, Marketing and Business Development groups within IlluminaWork closely with Marketing, Marketing Development, Assay/Product Development as well as commercial team and regional teams to support the execution of the launch strategy, ensuring internal and external launch readinessClinical Research: Identifies areas of unmet medical need for diagnostics. Devises the medical strategy for new products and articulates their potential medical value. Explores and defines potential clinical utility for company products. Required to work with the Clinical Affairs, BioStats, and Data Management teams to design, implement, interpret, report and publish clinical research studies to support product registrations. Identifies suitable academic partners, external laboratories and clinical sites to participate in clinical studies. Serves as the Company liaison with the Clinical and Medical groups within Illumina and other companies to identify and implement collaborative studies, regulatory activities and other projectsRegulatory Affairs: Works with other functional groups to define potential clinical utility claims for products. Provides medical/scientific input into and assists with the preparation of regulatory submissions (PMAs and 510ks). Prepares and provides responses to questions or requests for from regulatory agenciesQuality: Reviews product complaints to evaluate the potential clinical consequences of each complaint. Conducts medical reviews and provides medical opinions on complaints. Serves as a member of the Safety BoardDevelopment: Defines the intended use of products. Reviews and guides the development of product specifications to ensure that suitable attention is given to designing products that will be both safe and efficacious. Reviews the late-stage development programs for products to ensure that studies are designed and conducted to address any potential medical issues that arise from the performance or use of a product. This would include, for example, advising the Development teams on the therapeutic agents, organisms and other interfering substances to be explored in interference studies. Reviews results of studies conducted by the Development teams to ensure that products meet the requirements for safety and efficacy. Contributes to and reviews package inserts to ensure that customers are adequately informed of any issues that might affect safety or effective use of the productMarketing and Business Development: Works in collaboration with Marketing and Business Development to define suitable product requirements. Provides medical guidance to the marketing teams to ensure that marketing and promotional materials, etc., are both scientifically accurate and medically sound. Reviews publications by Illumina or external collaborators for scientific and medical content. Identifies and provides guidance on opportunities to jointly promote Diagnostic and Pharmaceutical scientific and medical data, in collaboration with Illumina and other companiesServes as Company expert to develop and/or give presentations at meetings and conferences on company products and the medical and clinical areas in which those products are to be usedConsults with key medical opinion leaders in relevant therapeutic areas, and provides guidance on the planning and implementation of adviser meetingsProvides training to internal and external customers on the disease areas in which current and future products will be used, and on the current and potential clinical utility of Illumina’s productsPosition Requirements:Advanced degree (i.e., MD, PhD, or Advanced Clinical degree i.e., MSN) with 10 years’ experience in Oncology, or related field, with relevant experience in clinical and collaborative research5+ years of applicable industry and leadership experience with a proven ability to design clinical trials, and critically evaluate study resultsSolid understanding of medical treatment / patient management and clinical workflowsThorough knowledge of clinical trial design and statistical methods for clinical researchHave demonstrated an ability to design studies, and write and review the resulting study reports and publicationsExcellent organizational, communication, and project management skills are essentialExperience in interfacing with key opinion leaders including physicians and clinical laboratoriansMust be able to travel domestically and internationally 10-20%PreferredBoard Certified in Internal Medicine, Oncology, with relevant clinical experienceA solid understanding of outpatient health systems (eg, clinical workflows) and clinical laboratory testing5+ years of clinical research experience with a proven ability to design studies, and critically evaluate study results in OncologyExperience within the diagnostics or pharmaceutical industry, with a track record of FDA clearance or approval based on clinical trialsThorough understanding of product development process for medical productsUnderstanding of the regulatory requirements under which diagnostic and/or pharmaceutical products are developed, commercialized, and supported after saleAbility to build and foster global relationshipsOther Qualifications:Prior experience with oncology diagnostic testing technologies preferredDemonstrated expertise in molecular diagnostics, next generation sequencing technology, genetics/genomicsUnderstanding of regulatory environment to conduct clinical trials for medical devices in the diagnostic industryDemonstrated ability to design clinical studies and write/review clinical study protocols, reports and publicationsFamiliarity with design control processes for product development preferred.Excellent written and oral communication skills, including speaking in front of small and large groups at executive level.#LI-REMOTEAt Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. 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