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Vice President of Discovery and Translational Research

Location: Boston, MA, United States
Job # 11764027
Date Posted: 01-02-2019

Vice President of Discovery and Translational Research

at Pear Therapeutics
San Francisco
Organization Statement:
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 lead 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. For more information, visit us at www.peartherapeutics.com.
* reSET-O™ and reSET® are registered trademarks of Pear Therapeutics, Inc.
Description:
The VP of Discovery and Translational Research (VP DTR), will be a key leader in pioneering novel therapeutics and moving them from Discovery, thru Translation, and into clinical development.  The VP DTR will be responsible for leading and managing a team of clinical directors and discovery scientists whose function is to map disease area biology, identify mechanisms of action, screen and refine lead candidates and then the operational implementation of translating into clinical activities to advance Pear Therapeutics’ prescription digital therapeutics through clinical trials and regulatory review.
This position will involve extensive coordination internally at Pear with the Chief Medical Officer, Product team, Clinical Development Team, Clinical Operations Team, Regulatory Affairs and Quality Assurance. The VP of DTR will form a tight alliance with Clinical Development and Corporate Development to integrate resources, to lead operational activities between functions, to identify safe and effective therapeutics, achieve preliminary efficacy in translational studies, improve efficiency, minimize costs of execution while meeting timelines. The VP of Discovery and Translation will collaborate externally with Pear’s partners on clinical programs.
Responsibilities:
  • Discovery and Translation, with a focus on screening, identifying leads, and designing novel therapeutics, often in combination with pharmacotherapy and translating into clinical studies
  • Designing and conducting Translational Clinical Trials, in collaboration with the ClinOps Team
  • Collaboration on Proof-of-Concept (Phase 2-equivalent) Clinical Trials with the Clinical Development team
  • You will be responsible for the team and ultimate results of planning, design and execution of Discovery and Translational activities, including disease area and biology mapping, mechanism of action screening, embodiment, translation and preliminary efficacy into the clinic
  • Studies will be conducted utilizing Pear’s Clinical Operations team and Pear’s partners
  • Continuing to optimize Pear’s Discovery and Translational process
  • Manage the Clinical Directors and Discovery team, responsible for each of Pear’s Pipeline Programs
  • Collaborate with Clinical Development and other relevant stakeholders, internal and external, on abstract, posters, and publications
  • Support Corporate Development on Portfolio and Disease Area Strategy
  • As appropriate, conduct Investigator meetings, Clinical/Scientific Advisory Boards and Key Opinion Leaders with Clinical Development
Qualifications:
  • Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of Discovery, candidate production, screening, lead identification and advancement
  • Experience in Translational Clinical Studies in humans (animals as well preferred)
  • Experience with pharmacotherapy and neurobehavioral interventions, a plus
  • Experience Planning, Designing and Conduction FDA grade clinical-trials
  • Track record of building and managing high-performing team and working collaboratively with Clinical Operations team
  • Excellent scientific written and oral communication skills are required.
  • A proven ability to work highly effectively with multiple teams with different backgrounds and cultures
  • Capable of working with attention to detail in a time sensitive environment and maintain a sense of urgency amongst team and colleagues.
  • Strong familiarity with good clinical practices (GCP) and International Conference on Harmonization Guidelines
  • We seek someone who can maintain a professional relationship with therapeutic area opinion leaders worldwide, and is equally comfortable discussing the science and research approaches that are critical for study protocol design, clinical endpoints and data interpretation.
  • Innate flexibility to work in a rapidly growing matrixed environment. Strong leadership skills with an ability to set a vision, lead change, and mentor others.
  • Strategic thinker with ability to formulate, develop and execute clinical strategies.
  • Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
Education and experience:
  • 5+ years of relevant experience in industry with an MD, PhD, or MD/PhD,
  • Residency and Clinical Practice experience strongly preferred
  • Working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical development.
  • Demonstrate experience in clinical design and implementation of Phase 1 to Phase 2 Proof-of-Concept Clinical studies, with direct leadership of trials that meet the timelines, budget, expected outcomes and lead to regulatory success of innovative medicines
  • Clinical Pharmacology experience a plus
  • Experience with neurobehavioral intervention
 
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