Job Summary: We are seeking an experienced, motivated Senior Medical and Scientific Affairs Manager eager to join a fast-growing, Boston-based start-up. Your role at Selux will be instrumental in transforming Infectious Diseases patient care and combating the antibiotic resistance epidemic. Selux's diagnostic platforms, including the 510k cleared Positive Blood Culture Separator and Rapid Antibiotic Susceptibility Test system, are the result of our ongoing registrational and non-registrational sponsored studies and research collaborations.

The successful candidate will become a critical part of the Selux team, leading clinical trial and medical affairs activities and serving as the primary point of contact with study staff and KOLs. This position can be remote, with the expectation of up to 25-30% travel to the Selux headquarter in Boston and to study/customer sites. The clinical trial responsibilities will include supervising study monitors and working closely with the Project Manager, VP of Regulatory and Quality Affairs, Chief Technology Officer, and Senior Director of R&Dto ensure clinical trial milestones are achieved on time and within budget. This position offers not just a long-term commitment, but also a unique opportunity for growth and learning about Regulatory strategy. Selux plans to perform at least 4 FDA trials over the next 5 years with this position leading each, providing a platform for you to expand your skills and expertise. 

Key Responsibilities:

• Oversee all aspects of clinical trials and research collaborations, including protocol and reporting writing, study initiation, monitoring closeout, inventory, quality, and regulatory compliance.
• Lead and supervise data capturing, monitoring, data management, and data analysis aspects of the study.
• Serve as the Medical and Scientific Affairs representative and primary contact for internal cross-functional teams and study collaboration institutions.
• Working with cross-functioning teams for continual improvements such as process improvements and SOP and working area instruction writing
• Establish and maintain relationships with key opinion leaders such as lab directors, pharmacists, and infectious disease doctors, as well as support research collaborations and investigator-initiated studies.
• Support publications and medical education and communications.
• Other duties as assigned.

Preferred Qualifications:

• A Bachelor’s degree or higher in a scientific or biological discipline (microbiology experience preferred, advanced degree preferred)
• 7-10 years of clinical research experience in the medical device/IVD industry
• Experience in leading company-sponsored registrational and non-registrational trials
• Experience in KOL and customer relationship building
• Analytical and creative thinking skills
• Excellent attention to detail and the ability to keep detailed, accurate records
• Experiences in scientific research methods and publications, including medical writing
• Strong written and verbal communication skills
• Ability to work collaboratively and problem-solve.
• Proficiency in MS Word, Excel, and PowerPoint
• Organizational and planning skills
• Ability to travel to US-based sites and customer locations (~20-30% travel)
• Passionate about an early-stage start-up that aims to change industry and how healthcare is delivered!

This is a bonus eligible role with a target salary range of $130K-$180K.