EugeneRecruiter Since 2001
the smart solution for Eugene jobs

Clinical Development Consultant

Company: Pear Therapeutics
Location: Remote
Posted on: November 22, 2021

Job Description:

About Pear Therapeutics:

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 therapeutic areas, including severe psychiatric and neurological conditions. Our first product, reSET -, treats Substance Use Disorder and was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear's second product, reSET-O -, for the treatment of Opioid Use Disorder, received marketing clearance from the FDA in December 2018. Pear's third PDT, Somryst -, is the first FDA-authorized prescription digital therapeutic (PDT) for patients with chronic insomnia and the first product submitted through FDA's traditional 510(k) pathway while simultaneously reviewed through FDA's Software Precertification Pilot Program

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
* You must be fully vaccinated against COVID-19 prior to your start date, and must remain fully vaccinated throughout employment, including receipt of booster doses as recommended by federal, state, and/or local health authorities, unless an accommodation is granted by Pear for medical or religious reasons in accordance with applicable law.

Equal Employment Opportunity

Pear Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion or religious creed, ancestry, age, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), sexual orientation, gender identity or gender expression, national origin, genetic information, qualified physical or mental disability or handicap, medical condition, qualified military or veteran status, or any other basis protected by applicable law. Pear Therapeutics also follows all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leave of absences, compensation and training.#06022021

Keywords: Pear Therapeutics, Eugene , Clinical Development Consultant, Healthcare , Remote, Oregon

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Oregon jobs by following @recnetOR on Twitter!

Eugene RSS job feeds