May 19, 2021
San Francisco Bay Area, CA, USA
Pear Therapeutics is the leader in prescription digital therapeutics (PDT). 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 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. 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.
As Global Clinical Lead, SUD/OUD, you will manage all aspects of clinical development for Pear’s substance use disorder/opioid use disorder program. Open, effective, and proactive communication of the clinical development activities is critical for success in this role. The successful candidate will provide leadership and program oversight to plan and conduct one or more high-quality clinical trials concurrently in accordance with FDA, CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions as well as post-authorization studies. In addition, this role provides clinical input to the Commercial activities of authorized products. This position reports to the VP, Research and Development.
Lead a cross-functional project team(s) in the strategic, tactical, and day-to-day execution of a clinical development program
Actively participates in the Program Steering Committee which oversees the strategic and tactical development of the PDT, its clinical development, and its marketing and commercialization
Participates in the Medical Affairs strategy including publications and external studies for reSET® and reSET-O®
Typically leads clinical trials from concept to protocol to clinical study report, in accordance with company objectives and timelines
Provides clinical insight into the features, content, and mechanisms of action of developing PDTs
Oversees investigative sites' adherence to regulations through review of monitoring reports, QA-GCP audit reports, and communications with investigators, study site personnel, and Clinical Research Organization (CRO) team members
Supports Clinical Operations with budget builds, vendor selection, and compliance for assigned program
Develop and maintain relationships with Key Opinion Leaders; participate in Advisory Boards as needed
Assists with regulatory (FDA, Competent Authority) and local IRB and Ethics Committee submissions and subsequent responses
Reviews clinical documents (i.e., protocols, amendments, clinical study reports) and clinical sections of regulatory documents (i.e. annual reports, annual or periodic safety reports, IDE, De Novo, 510k and NDA/BLA/505(b)2 filings) for accuracy, consistency, and quality
Contributes to the improvement of processes, systems, tools, procedures; may contribute to SOP review, development, and adherence
Performs other duties as assigned
Ability to travel up to approximately 20% when safe to do so post-COVID-19 pandemic
An advanced degree (MD, Ph.D., PharmD, PsyD, or DO) with 10+ years in Addiction Medicine is strongly preferred
The candidate should have a minimum of 10+ years of clinical research experience including clinical trial design.
Experience in late phase clinical studies and commercialization of products
Working knowledge in the operational aspects of managing phase 1-4 clinical studies from start-up to closeout, vendor management, and planning cross-functional operational activities
Experience with digital and/or user research, usability, and/or human factor studies a plus
Excellent working knowledge of Human Subjects ICH GCP guidelines, FDA, CFR, EMA, and HIPAA regulations
Able to work independently and make appropriate strategic decisions to operationalize and move clinical trials forward
Excellent written and oral communication and presentation skills
The ability to manage multiple priorities, while maintaining attention to detail is critical
Experience in operating effectively within a matrixed environment, specifically in a healthcare/pharmaceutical start-up setting
Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
Possess strong and influential leadership skills with proven ability to lead internal and remote team members at all levels
Enjoys working in a fast pace environment and not afraid to get into the weeds of a project
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.