Happify Health is a LifeTech company whose mission is to improve access to mental, physical and chronic care through a single digital self-care platform while driving mass-market adoption of Digital Therapeutics. We are a collective of scientists, researchers, clinicians, content creators and AI engineers united to solve some of humanity’s greatest health challenges. Our clinically-validated platform provides global access to one of the most comprehensive, evidence-based intervention catalogs available, resulting in better health and business outcomes for people and organizations.
About the Role
Happify Health is hiring a Clinical Research Scientist to design and manage research in our digital therapeutics department. These studies will include observational studies, randomized controlled trials, and real-world evidence studies with a variety of populations. This job reports directly to the Chief Science Officer.
- Oversee key studies in Happify Health’s digital therapeutic pipeline (mental health, as well as chronic illness) with a variety of different methods (observational, RCT, qualitative)
- Design clinical research studies consistent with Good Clinical Practice (GCP) and in line with company SOPs.
- Oversee process of creating detailed protocols suitable for submission to Pharma partners and/or FDA, including: drafting scientific portions of the protocol, managing strategic aspects of study design and keeping on top of logistical aspects.
- Work with biostatistics consultants to generate statistical plans that meet FDA expectations and company needs.
- Work with team to gather relevant research on assigned therapeutic areas, educate company on those areas, and stay up to date on relevant new research developments (including competitor research activity).
- Collaborate with Regulatory to assist in drafting of FDA submissions, including submission of research protocols to FDA.
- Work with Clinical Operations Team to design case report forms and draft consent forms.
- Author publications and give presentations relevant to research projects.
- Take an active role in the recruitment of potential academic sites for collaboration, as well as other research collaboration relationships.
- Ph.D. in Clinical Psychology or related field, or MD. Other degrees with suitable experience would be considered. Active clinical licensure desired, but not required.
- Experience with chronic health disorders that are exacerbated by stress (e.g., diabetes, hypertension, etc) and/or associated with mental health concerns also strongly desired. Please indicate areas of expertise in cover letter.
- Experience with the clinical trial process, ideally overseeing an entire study, is preferred.
- Willingness to train on and follow clinical research SOPs in compliance with ISO 14155 is required. Prior experience with ISO 14155, FDA 812, GCPs, and adhering to SOPs is preferred.
- Established record of publishing clinical trials, including familiarity with CONSORT guidelines and clinicaltrials.gov registry, is strongly preferred.
- Strong presentation skills and the ability to present to a variety of audiences, from highly technical (e.g., FDA, other clinical scientists) to broader audiences (e.g., investors, health care executives).
- Experience in the digital therapeutics space and/or in a startup environment is desirable, but not required.
- Ability to be based in or travel to the Burlington, MA office 2-3 times per year for up to a week.