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Clinical Lead, Schizophrenia Program

Location: Boston, MA, United States
Job # 10359850
Date Posted: 01-26-2018

Clinical Lead, Schizophrenia Program

at Pear Therapeutics
Boston or San Francisco
 
Organization Statement:
Pear Therapeutics is the leader in FDA-cleared prescription digital therapeutics. The company’s approach is to integrate clinically-validated software applications with previously approved pharmaceuticals and treatment paradigms to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear’s lead product, reSET®, is an FDA-cleared 12-week interval prescription therapeutic for Substance Use Disorder (SUD) to be used as an adjunct to standard, outpatient treatment. Pear’s product development pipeline includes reSET®-O™ for opioid use disorder (OUD) and additional prescription digital therapeutics in schizophrenia (Thrive™), combat posttraumatic stress disorder (reCALL™), general anxiety disorder (reVIVE™), pain, major depressive disorder, and insomnia, for which Pear intends to obtain FDA clearance. For more details, please see www.peartherapeutics.com.
 
Description:
As the Clinical Lead for the Schizophrenia program, you will manage all clinical aspects of the Schizophrenia clinical development program.  Your two primary responsibilities will be (1) lead and manage construction of clinical therapeutic content for safe and efficacious Schizophrenia-targeted digital therapeutics, and (2) lead and manage your program’s clinical development activities from Target Product Profile (TPP) thru Translational, Randomized Clinical Proof-of-Concept, and Pivotal/Registration Trials demonstrating safety and efficacy of the digital therapeutic. Key contributions include clinical content development and management of clinical studies.
Clinical practice experience in patients with schizophrenia as well as experience contributing to designing and conducting of randomized clinical trials is essential.  Capacity for open, effective, and proactive communication of clinical development activities is critical for success in this role.  The ability to manage your clinical program team, work across related teams and across functional areas, including Product, Engineering, Data Science is a must.  Bring a problem-solving, collaborative, humble and learning mindset.
The successful candidate will provide leadership, domain expertise, project management, and program oversight to plan and conduct multiple high quality clinical trials concurrently in accordance with FDA, CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions in a timely manner to meet firm objectives.
 
Responsibilities:
  • Lead and manage schizophrenia clinical development program from TPP through clinical trials, regulatory submission, and beyond
  • Provide expert medical advice to the Program team for the clinical development of digital therapeutics
  • Lead and manage origination and generation of therapeutic and clinical content for therapeutic application
  • Work closely with Product team and Product Manager, Designers, Data Science, Engineers and other key cross-functional stakeholders
  • Provide direct medical input and source external expert input into development of the TPP and subsequent therapeutic content and logic for product development team
  • Lead/participate in ad hoc investigator meetings, advisory committee meetings.
  • Coordinate and represent Clinical at Regulatory meetings as Clinical Lead
  • Design and supervise Pear sponsored clinical trials, user research studies as well as participate in medical interpretation of data analyses and safety reviews
  • Originate, review and provide valuable input into clinical documentation to support clinical development and regulatory filings (e.g. clinical protocols, CRFs, Statistical Analysis Plans, Clinical Study Reports) to ensure scientific and medical accuracy
  • Responsibilities may include post marketing commitments and life cycle management initiatives
  • Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
  • Contribute to the generation and review of documents for regulatory submission/communications (e.g. pre-submission meeting packages, De Novos, 510ks)
  • Contribute to scientific publications, provide consultation on medical subjects to investigators and other company personnel, establish rapport with site personnel, external authors and key opinion leaders and searching and analyzing medical literature
  • Remain up to date with current information on product regulations, guidelines and practices and therapeutic area knowledge
  • Assist with clinical assessment of new business development opportunities as needed
 
Requirements: Minimum Qualifications:
  • D., M.D./Ph.Ds, Ph.Ds, or D.O. required, schizophrenia/psychotic-spectrum disorders experience required
  • Specialty training with a minimum 3-5 years’ experience working in Clinical Practice, Consulting, Clinical Development in the Biotech, Digital or Pharmaceutical industry
  • Facility with digital applications, concepts, tools, language
  • Strong collaborative interpersonal and communication skills, ability to problem solve and work in a fast-paced environment.
  • Ability to travel 25-30% of the time
  • Ability to participate in early and after-hours events and calls
 
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, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. 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. All applicants must have authorization to work for Pear Therapeutics in the U.S. In certain circumstances it may be advantageous to Pear Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pear Therapeutics and the specific job and/or work site. Pear Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship disclosure, when initial application for employment is made, whether or not they are legally authorized to in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pear Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pear Therapeutics.
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