About Pear Therapeutics:
Pear Therapeutics is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, & delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement & tracking tools for clinicians, & cost-effective solutions for payers. Pear has a pipeline of products & product candidates across therapeutic areas, including severe psychiatric & neurological conditions. Our lead product, reSET, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pears second product, reSET-O, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018. For more information, visit us atwww.peartherapeutics.com.
As aManager of Clinical Operations (Contract), you will manage all operational aspects of clinical development projects for one of Pears programs. Open, effective, & proactive communication of the clinical development activities is critical for success in this role. Candidate will provide leadership, project management, & program oversight to plan & conduct one or more high quality clinical trials concurrently in accordance with FDA, CFR, EMA, & ICH GCP regulations in support of regulatory authority submissions as well as Discovery, Translational & Product Improvement User Research, Feasibility & Engagement Clinical Studies.
- Actively participates in cross functional project teams representing clinical operations from a tactical & day-to-day execution perspective
- Typically leads several user research & clinical trials simultaneously, from concept to protocol to clinical study report, in accordance with company objectives & timelines.
- Leads the development of the protocol & other study documents, e.g. consent templates, study reference manual, monitoring plan, data management plan.
- Participates in assessment & selection of Contract Research Organizations (CROs), when relevant, sites, & other vendors; may perform qualification visits as needed, solicit & review proposals, review or negotiate budget & Scope of Work.
- Primary responsibility for patient sourcing, recruitment & enrollment to achieve FPI & LPO in accordance with timelines
- Oversees investigative sites' adherence to regulations through review of monitoring reports, QA-GCP audit reports & communications with investigators, study site personnel & Clinical Research Organization (CRO) team members
- Maintains performance & quality metrics for clinical study conduct
- Manages vendor relationship & follow-through, as needed
- Support Director of ClinOps with budget build & compliance for assigned program
- Assists with regulatory (FDA, Competent Authority) & local IRB & Ethics Committee submissions & subsequent responses.
- Reviews clinical documents (i.e. protocols, amendments, clinical study reports) & clinical sections of regulatory documents (i.e. annual reports, annual or periodic safety reports, IND, DeNovo, 510k & NDA/BLA/505b2 filings) for accuracy, consistency & quality.
- Contributes to the improvement of processes, systems, tools, procedures. May contribute to SOP review, development & adherence
- Performs other duties as assigned
- Ability to travel up to approximately 20%
- BS/BA degree required in science/health-related field. A Masters or doctorate degree is preferred.
- The candidate should have a minimum of 5-10 years of clinical research and/or clinical project management experience
- Experience in the operational aspects of managing phase 1-3 clinical studies from start-up to closeout, vendor management, & planning cross-functional operational activities
- Experience with digital and/or user research, usability, and/or human factor studies a plus
- Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, & clinical supplies management
- Excellent working knowledge of Human Subjects ICH GCP guidelines, FDA, CFR, EMA, & HIPAA regulations.
- Able to work independently & make appropriate strategic decisions to operationalize & move the clinical trials forward.
- Excellent written & oral communication & presentation skills
- The ability to manage multiple priorities, while maintaining attention to detail is critical.
- Experience operating effectively within a matrixed environment, specifically in a healthcare/pharmaceutical start-up setting.
- Ability to prioritize tasks & resources, meet deadlines, & be flexible to changing priorities
- Possess strong & influential leadership skills with proven ability to lead internal & external team members at all levels.
- Enjoys working a in a fast pace environment & not afraid to get into the weeds of a project
Equal Employment Opportunity:
Pear Therapeutics is committed to equal opportunity in the terms & conditions of employment for all employees & job applicants without regard to race, color, religion or religious creed, ancestry, age, sex (including pregnancy, childbirth, breastfeeding & 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 & local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration & Nationality Act. This policy applies to all terms & conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leave of absences, compensation & training.