Pear Therapeutics is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, and delivering clinically validated, software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across multiple therapeutic areas including severe psychiatric and neurological conditions. Our lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from FDA to treat a disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing authorization from FDA in December 2018, and Somryst®, developed for the treatment of chronic insomnia, was our third product to receive marketing authorization from FDA. For more information, visit us at www.peartherapeutics.com.
Summary
Pear has numerous projects including advancing the clinical development programs for prescription digital therapeutics. The therapeutic areas include alcohol use disorder, schizophrenia, bipolar disease, opioid use disorder, major depressive disorder, and generalized anxiety disorder.
Overall objective is to design a data package for FDA authorization of a prescription digital therapeutic.
The consultant(s) will work with an internal team to deliver a Target Product Profile (TPPs) and a clinical development program(s). The clinical development program is to include the design of a proof-of-concept study and a pivotal/registration study along with the corresponding trial synopsis and timeline. As appropriate, interactions and feedback from the relevant regulatory authorities will occur.
Qualifications:
- Advanced degree (PhD, MD, PsyD or DO) in psychology, psychiatry, neuroscience, or addiction medicine
- Clinical and/or research experience (at least 5 years) in:
- psychotherapy particularly cognitive behavioral therapy
- one or more of the following: alcohol use disorder, schizophrenia, bipolar disease, opioid use disorder, major depressive disorder, generalized anxiety disorder, addiction medicine
- digital health preferred but not required
- Clinical trial design and execution, particularly Phase 3, pivotal/registration studies, is critical
- Experience with regulatory authority interactions and submissions such as NDA, ANDA, BLA, 510k and/or De Novo
- Submit your resume with letter of interest.