Medical Director- Med Peds
Behavioral Health Market Context
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Qualifications
- •Advanced degree in Medicine (MD or equivalent)
- •Board-certification in Med/Peds or Pediatrics
- •7+ years of demonstrating clinical & research excellence within academia and/or pharma
- •Experience as a Principal Investigator with a focus on pharmaceutical-sponsored studies
- •Expertise in project management - Demonstrates ability to successfully lead/manage research personnel
- •Proactive problem-solving abilities and follow through
- •Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment
- •Successful decentralized team management and situational responsive decision-making
- •Extensive knowledge of clinical research - Understands the drug development process
- •Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities
- •Ability to create and review protocols, programs, and assess the feasibility/pathway to success of a project
- •Strong communication and presentation skills - Demonstrates strong written and verbal communication skills
- •Ability to establish and maintain positive sponsor, project team members and internal Science37 relationships
- •Ability to conduct effective presentations
- •Computer skills - Working knowledge of MS Office suite and Google applications
- •Able to generate business correspondence, create forms and generate reports as required
- •Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, responsibility, and flexibility to get the work done
- •Other – Ability to communicate in English (both verbal and written)
- •15 more items(s)
Responsibilities
- •This is a full-time, remote position and the individual chosen to fulfill this role can work from home
- •Function as the Principal Investigator for clinical trials when Science 37 is executing studies as either a Direct to Patient Site or fully decentralized trial
- •Function as a Sub-Investigator for clinical trials for therapeutic areas/ indications that align with clinical expertise/ experience when Science 37 is executing studies
- •Coordination with Site Operations Manager to identify, onboard and train investigators for Science 37 studies
- •Educate and train Science 37 study team about target patient population and treatment paradigms for given indication for Science 37 studies
- •Support for Science 37 Commercial Team
- •Collaboration with Business Development counterpart to review study opportunity synopses/protocols to assess fit/feasibility for decentralized trial model
- •Support Business Development counterpart during sponsor/client meetings and teleconferences
- •Support Science 37 study opportunities as a subject matter expert in the development of study opportunity proposals
- •Regulatory Engagement
- •Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies regarding the decentralized trial model, and its acceptance for global studies
- •Work with sponsors/collaborators to identify clinical endpoints that are fit for decentralized clinical trial conduct
- •Collaborate with sponsors and regulatory bodies to migrate endpoints from clinic-based conduct and validate their use for in-home conduct
- •Thought Leadership
- •Serve as Science 37 representative for decentralized clinical trial and therapeutic area-specific expertise at industry/clinical conferences and webinars
- •Publish peer-reviewed articles and white papers related to therapeutic area-specific expertise and the decentralized clinical trial model
- •13 more items(s)