Happify Health
Published
January 11, 2021
Location
Telecommute
Category
Job Type
Work Setting
Remote / Home-based

Description

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.

Responsibilities:

  • 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.

Qualifications

  • 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.
Apply
https://www.linkedin.com/in/your_name/
Drop files here browse files ...
Resume, cover letter, or other documents as required per the job description

Related Jobs

January 18, 2021
January 18, 2021
January 18, 2021
January 18, 2021
Are you sure you want to delete this file?
/