At Pear, our mission is clear: we are pioneers in Prescription Digital Therapeutics, or PDTs. Our cross-functional team operates at the intersection of biotechnology and software technology. Pear discovers, develops, and delivers clinically-validated, software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers.

Every day, we push the boundaries of technology to transform medicine. Pear has a pipeline of products and product candidates across therapeutic areas, including mental health disorders, severe insomnia and multiple sclerosis. Our lead product, reSET®, treats Substance Use Disorder, and was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O™ for the treatment of Opioid Use Disorder, also received market authorization from the FDA in December of 2018, with breakthrough designation.

Description

The Global Clinical Lead for the Multiple Sclerosis (MS) program will manage all clinical aspects of the MS clinical development program. Your two primary responsibilities will be to (1) lead and manage the construction of clinical therapeutic content for safe and efficacious MS targeted digital therapeutics, and (2) lead and manage the MS programs 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 MS as well as experience contributing to designing and conducting of randomized clinical trials is essential. Clinical experience and insight into managing disease progression of patients with MS, including symptoms and co-morbid manifestations/conditions such as depression, fatigue, cognitive impairment, and others. Open, effective, and proactive communication of clinical development activities is critical for success in this role. The ability to lead and manage your clinical program team and work across related teams and across functional areas, including product, engineering, and 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 the Multiple Sclerosis (MS) 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 the Product Team, 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 and participate in ad hoc investigator meetings and advisory committee meetings
  • Coordinate and represent Clinical at Regulatory meetings
  • Design and supervise Pear sponsored clinical trials, user research studies as well as participate in medical interpretation of data analyses and safety review
  • 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

• • M.D., M.D./Ph.Ds, Ph.Ds, or D.O. is required
  • Multiple Sclerosis experience is required
  • Neurology specialty training with a minimum 3-5 years of experience working in Clinical Practice, Consulting, Clinical Development in the digital biotech or pharmaceutical industry
  • Licensed and Board-Certified in Neurology is strongly desired
  • Facility with digital applications, concepts, tools,and language
  • Strong collaborative, interpersonal and communication skills, ability to problem solve and work in a fast-paced environment
  • Must be available to participate in early and after-hours events and calls
  • Must be available to travel up to 30% of the time

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.

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