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Manager, Medical Scientific Affairs- SII
4 months ago
Overview
Find a Better Way...
...to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
...to build a promising future.
Responsibilities
We currently have a great opportunity available for a Medical Scientific Affairs Manager - SII. The Manager of Medical Affairs will play a pivotal role in supporting our clinical study portfolio and spearheading the generation of scientific evidence and publications. They will cultivate and maintain clinical collaborations and professional relationships with leading healthcare providers and decision-makers relevant to Sysmex Inostics' products. Staying abreast of diagnostic and treatment trends, as well as scientific literature, will be paramount.The Manager of Medical Affairs will actively engage with professional stakeholders to gather scientific insights crucial to our medical strategy and clinical research for Sysmex Inostics' NGS-based sequencing test portfolio. Exceptional organizational skills and proficiency in study data management will be essential for supporting the analytical and clinical validation of Sysmex assays using clinical samples.They will be instrumental in executing investigator-initiated studies and trials while providing indispensable technical and logistical support for pharmaceutical clinical studies. Effectively communicating data to pharmaceutical customers and key opinion leaders, and assessing the efficacy and limitations of our assays for specific clinical applications, will be integral to the role.Furthermore, this position will serve as a vital link between the external medical community, including physicians and oncologists, and the management of testing activities within the CLIA laboratory.
Essential Duties and Responsibilities:
1. The Manager of Medical Affairs oversees medical aspects of new assay development and on-market vigilance within the United States.2. Review and summarize results for upper management, and effectively communicate findings to oncologists and pharmaceutical companies. Oversee clinical study progress and manage timelines for publication of clinical studies.3. Oversee consultants providing biostatistical and scientific writing support for Medical Affairs, Regulatory Affairs, and Marketing initiatives.4. Coordinate literature reviews to bolster clinical development efforts.5. Cultivate and manage relationships with key opinion leaders (KOLs) and provide support for the Sysmex Inostics Scientific Advisory Board.6. Provide support for marketing endeavors aimed at external customers and assist sales in reviewing proposals, quotes, and study designs.7. Offer support to a laboratory applications team in Baltimore to optimize workflows, product design, and clinical patient testing operations.8. Serve as a crucial clinical science liaison between translational science/product design and QA/RA functions in Baltimore.9. Collaborate with Translational Science, Laboratory Operations, Quality and Regulatory teams, Sales, as well as Research and Innovations teams to ensure seamless integration and alignment of efforts.10. Other duties as assigned.
Percentage of Travel: Ability to travel 15 - 25%.
Physical Risk: Regular exposure to risk that may require alertness, but with minimal precautions.
Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.
Qualifications
* Bachelor's degree in life/ biological science or related field plus 5 years diagnostic experience OR • Master's degree in life sciences or related field plus 3 years diagnostic experience OR• PhD in life sciences or related field preferred, with 1-2 years of diagnostic experience in clinical diagnostic companies/laboratories, along with prior experience in diagnostic assay development, on-market product launches, and performance surveillance. The role demands strong scientific acumen, clinical product positioning abilities, and excellent communication skills.
* Experience in translation clinical research and execution of studies to generate and publish evidence.• Highly proficient in data management, interpretation, study execution, and evidence publication, highlighting clinical performance of diagnostic assays.• Exceptional verbal and written communication skills, adept in PowerPoint, Excel, and statistical analysis software (e.g., JMP).• Demonstrated passion for the life sciences and driving innovative technologies to market for the betterment of patients.
* No foreign language skills required, international travel experience desirable,excellent communication skills.
* MS Office, PowerPoint, Excel, statistical programming, CRM database (i.e., HubSpot).
* Solid cross-functional teambuilding skills to bridge translational science, clinical intended uses of assays, and business strategy. • Self-starter with the ability to work independently and as part of a vibrant Medical Affairs as well as external physicians/laboratorians/principal investigators
Salary range $125-138K
This job requires satisfaction of the credentialing requirements of Sysmex's customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19. Further, Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual's ability to provide proof of current vaccination status to the extent permitted by applicable law. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job including working at customer locations.
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
