Clinical Operations Manager

The Role

The Clinical Operations Manager will work closely with the CEO and CTO to design, execute and manage the company’s multiple clinical studies that we’re launching this year, from longitudinal and observational to evaluating novel therapies. You will build the company’s decentralized clinical trials platform, clinical data collection platform, and help the rapid translation of our science into clinical research by providing clinical data and feedback.

Who We’re Looking For

• You have a Masters, MD or PhD in disciplines related to clinical research and 2 years of relevant work experience.
• You have experience in clinical research and executing clinical trials from the industry or academic institutes such as biotech/pharmaceutical therapies, nutrition, genetic or genomic testing. You are fluent with requirements and can easily design and prepare clinical protocols, informed consent forms and work to obtain IRB approval. Bonus points if you have experience running decentralized or virtual trials, either by yourself or with a CRO, or if you have experience with running trials in a community setting.
• You have good clinical practice training. You may have certifications such as Clinical Research Associate or Clinical Data Manager and good working knowledge of FDA regulations and clinical development. You’re comfortable designing and working with databases.
• You are excited by how genomics can change medicine. You have a basic understanding of bioinformatics or computational biology and sequencing technologies. You are passionate about the microbiome.
• You are mission driven. You like to see immediate impact on patients, want to have an impact on the team and the company, like to get your hands dirty and are happy to go above and beyond.
• You are flexible and organized. You’re detail oriented, value documentation, and enjoy working in a dynamic remote environment.
• You are entrepreneurial and collaborative. You are able to self manage, tackle challenges, and are a great communicator, both verbal and written.

Bonus points:

• You have experience working at a microbiome therapeutics or a direct-to-consumer sequencing company.
• You have a basic understanding of bioinformatics or computational biology and sequencing technologies.

Why Join Output Biosciences

By joining Output Biosciences, you’ll help shape the creation of a new category — preventative therapeutics — that will fundamentally change the way people live. You’ll be part of the early team pioneering a new era of drug development with unprecedented safety and speed to market. If you’re impatient to see how your work improves people’s lives and impacts the treatment and prevention of chronic disease, this is the place for you.

Our values:

• ❤️ Heart: We encourage a sense of ownership. We are building a team of people who care and take pride in their work.
• 📣 Honesty: Tell it as it is, and we’ll deal with it together.
• 🎮 Fun: Life’s too short, we want work to be fun as well.

What We Offer

• We encourage new and different ideas, creativity and contrarian thinking. We are looking forward to further shaping our culture with early team members. You’ll have a chance to make your mark!
• You own your day-to-day management. We don’t care when or where you work, we care if we all hit our milestones.
• Competitive salary and equity in a growing, well-funded startup
• Excellent medical, dental, and vision coverage
• Remote team, work in the way that’s best for you
• Healthy feedback focused environment to help you strive - leadership will have high expectations, regularly share constructive feedback, support you and help you grow, and welcome receiving feedback and ideas from you