Our mission is to make the best mental health tools radically accessible to everyone.
We’re a venture-backed startup building a suite of products designed to help people around the world improve their moods. Indeed, Woebot Health was created to address the growing gap between demand for, and access to, quality and evidence-based mental health services. We set out to solve the problem of access by creating scalable solutions that are both efficacious and engaging.
Our research on and expertise in clinical interventions and implementation science, coupled with digital therapeutic translation work, and rare expertise in artificial intelligence and machine learning, helped establish and strengthen us as a company.
Woebot Health. was founded on the following principles:
- Behavioral Health For Everyone: We believe that like physical fitness, emotional fitness is something that people can actively cultivate on a daily basis. Creating a cultural shift in this direction is a crucial pathway towards tackling the mental health crisis.
- Academic Rigour By Design: We are committed to demonstrating outcomes and contributing to the field. In addition, we apply best practices from human subjects research to our users and the protection of their data.
- Humans First: We practice human-centered product design principles. In essence, we listen to our users as well as pay attention to and design for their lived experience of mental health problems.
You will be a core member of the Research and Clinical Team, and will work with company stakeholders to help design and implement empirical evaluations of our digital therapeutics in national and/or international trials. You’ll work with our Clinical Operations Manager, and be a key part of leading our Research & Development Clinical efforts.
Why you should join our Clinical Team:
You’re excited to help us design and implement operational excellence in our evaluation of the clinical efficacy and safety of our digital therapeutics. You have the opportunity to work with cross-functional teams to bring Woebot’s mission to life: scaling access to quality mental health tools for millions.
You will be at the forefront of an emerging industry in digital health and wellness while being at the intersection of consumer and regulatory products. You have the unique opportunity to help delineate Woebot into a premium offering which will ultimately become the new standard in digital therapeutics.
We have an expansive program of research, our product is in high demand, and we’re excited to have people on our team that are just as passionate about mental health as we are.
About the role
Reporting to our Clinical Operations Manager, you will support the clinical operations of the Clinical / R&D Team which is responsible for Woebot Health’s (i) regulatory trials for products targeting FDA-clearance as well as (ii) provide support to the expansive programs of research for its suite of emotional support products. Successful Clinical Operations underlies the success of all of our trials. Thus, the Clinical Operations Lead must have a clear track record of operational excellence in clinical trial research in addition to exemplary communication, attention to detail, and organizational skills.
- Function as Woebot’s Clinical Trial Manager for our Regulatory Trials
- Act as the company’s primary liaison and develop and maintain client relationships with the CRO running our regulatory trial.
- Work with Clinical Operations Manager and CCO to contribute to CRO oversight, decision making, ensuring project progress and in addition, facilitate CRO contract details in preparation for pivotal trial launch and implementation.
- Managing and keeping up-to-date internal-facing pivotal trial + CRO timelines while communicating these clearly and regularly across teams
- Readily communicate all facets of study progress (e.g. budget details, recruitment challenges) to relevant stakeholders.
- Have deep foresight into study ops so that potential problems are identified and solutioned in advance. If a risk to study ops is identified post FPI, actively problem solve and eradicate the blockers swiftly and collaboratively.
- Leverage your deep clinical operations experience toward devising and implementing ops excellence in each study assigned
- Optimize for efficiency in study execution processes
- You initiate and manage sponsored and investigator-initiated research studies (i.e. study-startup, maintenance, close-out, monitoring, and protocol development)
- Function interdepartmentally -- primarily with Product and Commercial Teams -- toward active communications of research progress and attainment of study aims
- Execute against the Clinical / R&D Team’s core objectives
- Generate and refine study ops manual and protocols
- Contribute to and facilitate communications regarding external engagements and partnerships on behalf of Clinical and R&D, including study-related processes and documentation
- Contribute to vetting, initiating, and managing third party CRO vendor selection
- Proactively contribute to the creation and maintenance of operational guidelines, SOPs, and training manuals to support our growing trials & products
Key Performance Objectives
Within your first 30 days you will
- Read through core correspondence and submission documents between us and the FDA in order to deeply understand our proposed pivotal trial
- Educate yourself on our live clinical trials, research pipelines, and publications
- Immerse yourself in and adopt the platforms the Company and Clinical / R&D team utilizes (Asana, Lattice, Qualtrics)
- Learn our Standardization of Research Processes, including Clinical Ops process + Study Review Board Process
- Start your journey of getting to know Woebot - use the product daily
- Get up to speed on all the operational logistics. Attend meetings, review draft manuals, and familiarize yourself with our standard operating procedures.
- Get a basic understanding of the product profile and infrastructure for pivotal trials. You will gradually begin to lead and oversee all of our operations for our primary pivotal trial.
By Day 60 you’re actively contributing to the design and implementation of pivotal operations, triaging the action items, and reviewing and editing all manuals.
By day 90 you’re suggesting and implementing methods for improving team communication and efficiency for our clinical operations.
- Your deeply embedded with contributing to ongoing operational improvements and changes
- Actively engaging with the CRO for pivotal trial start-up and planning; communicating and timelining with Product Team accordingly
- Within your first 90 days, we expect that you’ve gathered a deep understanding of the product pipeline and research strategy, have been involved to a certain degree on all research programs.
- You’ll become a thought partner to our Clinical Ops Manager toward overall org operational excellence.
- Experience in working with 3rd party CROs to run registration clinical trials designed for regulatory approval and market submissions. Ideally within digital therapeutics, but pharma experience is welcome as well. Including budgeting and protocol generation.
- 3+ years of experience in human clinical research; demonstrated excellence in research operations for large scale, national, multi-site clinical trials with large sample sizes.
- Experience with taking products through registration trials and knowledge of associated challenges, timelines, and costs.
- A curious growth mindset and are also comfortable coaching other leaders by making suggestions and taking initiative on challenging and ambiguous problems.
- Clear track record of excellence in communication and organizational skills, attention to detail, and productivity
Our Core Values
- Empathic: Place a high value on user-experience. Motivated to help others be successful.
- Proactive & flexible: Hit the ground running. Even with ambiguity, you can get the job done.
- Driven: being willing to go the extra mile if needed to help support the team through big milestones
- Self-awareness and growth-mindset: Wants to learn and grow in the role.
- High standards: Take pride in your work and apply high standards toward everything.
- Strong work ethic: Work hard to get the job done.
- Excellence in communication and interpersonal fluidity
- Competitive Salary
- Stock Options
- Flexible PTO
- Health, Dental & Vision
- Healthy Snacks & Meals
Woebot is an equal opportunity employer and we deeply value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status