- 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.
- 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
- Relentless in the pursuit of our mission: We know that every second counts for patients and we are dedicated to saving lives and fighting antimicrobial resistance.
- Collaboration drives innovation: We're people people through and through. We love to work and play together and believe we are capable of more when we join forces as a community.
- Adapt with grace: The only way to achieve our goals is by staying flexible and positive when faced with uncertainty. We see challenges as opportunities to grow.
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SeLux Diagnostics Inc Boston, United StatesJob 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 resist ...
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Senior Manager/Director, Medical and Scientific Affairs - Boston, United States - SeLux Diagnostics Inc
3 weeks ago
Description
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:
About Selux:
Antibiotics are lifesaving drugs, but rapidly emerging antimicrobial resistance is threatening that reality. Selux's mission is to preserve the lifesaving efficacy of antibiotics by providing diagnostic results in hours, rather than days, and we are building a multidisciplinary team of talented individuals to help achieve this mission.
Joining the Selux team will give you an opportunity to harness your talent and advance your career by working in diverse groups of high-performing teammates tackling the most important healthcare challenges.
The customers and patients we serve have diverse life experiences and so do we. Selux is focused on hiring talented people from a wide range of backgrounds and providing an environment where everyone feels that they belong. We offer a competitive benefits package including healthcare, 401K match, stock option grants, open paid time off and supportive family leave policies.
Vaccination for COVID-19 is a requirement of employment.
Selux Diagnostics is proud to be an inclusive workplace and an Equal Opportunity Employer.
Our Values
We believe every member of the Selux team is an essential contributor to our vision of preserving the lifesaving power of antibiotics and that our strength lies not only in what we do, but how we do it. These values represent the way that Seluxors approach their work. If you're someone who is relentless, collaborative, and adaptable, Selux might be just the place for you
