The Clinical Operations Manager will work closely with the company’s management to design, execute and manage the company’s multiple clinical studies, that range from evaluating novel therapies to longitudinal and observational studies. You will plan and launch clinical trials, develop protocols, design data collection strategies and build trial documentation and SOPs. You will analyze quantitative study data, collect qualitative data from participants and produce clinical insights and reports to be shared with different stakeholders. You will help continue building the company’s decentralized clinical trials platform and clinical data collection platform, and help the rapid translation of our science into clinical research by providing clinical data and feedback. You will design recruitment strategies that increase participant enrollment and fit a decentralized clinical trial environment.
Who We’re Looking For
- You have a Masters, MD or PhD in in Life Sciences, Health Sciences, or in disciplines related to clinical research.
- You have at least 8 years experience in clinical research and in designing clinical trials in a biotech/pharmaceutical company or clinical research organization (CRO). You are fluent with requirements and can easily design and prepare clinical protocols, Informed Consent Forms and work to obtain IRB approvals. You have at least 1 year clinical research experience at a biotech/pharmaceutical company, with a preference to work experience in a small startup.
- You have experience running and scaling clinical trials. You have experience in recruiting subjects through more than one strategy, and in designing activities to ensure participant enrollment in a decentralized clinical trial environment.
- You have experience analyzing study data and discovering trends or insights. You can identify clinical subgroups within data or correlate clinical outcome with participant data. You have experience using statistical software or data visualization tools to present findings to stakeholders.
- 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, GCP and ICH guidelines and clinical development. You’re comfortable designing and working with databases.
- You are mission driven. You like to see immediate impact on patients, want to have an impact on the team and the company.
- You can work independently with a sense of ownership and proactively tackle challenges, even outside of your job description, while embracing ambiguity.
- You are flexible and organized. You’re detail oriented, value documentation, and enjoy working in a dynamic environment.
- You are patient, empathetic, and discreet. You have experience in dealing with trial participants and collecting qualitative data, and can do so in an objective, open, and non-biased way.
- You are entrepreneurial and collaborative. You are able to self manage, tackle challenges, and are a great communicator, both verbal and written. You are a team player yet function well independently.
- You are entrepreneurial and collaborative. You are able to self manage, tackle challenges, and are a great communicator, both verbal and written.
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
Joining Output Biosciences means that you will have the opportunity to make a significant impact on the development of a new category of therapeutics, which will fundamentally revolutionize the way people live. As a member of the early team, you will be at the forefront of a new era of drug development, characterized by unparalleled safety and speed to market. If you are passionate about making a difference in people's lives, and have a strong desire to contribute to the treatment and prevention of chronic diseases, then this is the perfect place for you.
- ❤️ Heart: We foster a culture of ownership. We are assembling a team of individuals who are passionate and take pride in their contributions.
- 🏆 Excellence: We have an unwavering commitment to excellence and continuously challenge ourselves to reach the highest standards.
- 🚀 Practicality: We value practicality and results-oriented thinking. We are committed to making a tangible impact on the lives of our patients and the broader community.
- 📣 Honesty: We place a high value on honesty and directness. We firmly believe in addressing issues as they arise, in an open and transparent manner.
- 🎮 Fun: We believe that life is too short to not have fun. That's why we're committed to creating an engaging and enjoyable work environment. Our goal is to create a workplace that is fun, rewarding and fulfilling.
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
- 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