Medical Director- Pediatric
POSITION OVERVIEW
Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research
The Medical Director is a leader of the Science37 clinical team. Working within the department of Medical Affairs, this individual is responsible for a broad range of activities across several core functions. We are seeking an energetic physician to help drive innovation in the clinical research ecosystem. This is a full-time, remote position and the individual chosen to fulfill this role can work from home.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
Science 37 studies
- Function as the Principal Investigator for clinical trials when Science 37 is executing studies as either a Metasite 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
QUALIFICATIONS & SKILLS
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
Skills/Competencies
- 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).
- Preferred knowledge of Spanish
REPORTING
- Position Reports to the Chief Medical Officer
Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
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