Science 37

Title: Medical Director- Med Peds Location: United States Job Description: 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 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 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’s Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37’s extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout. The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37’s decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures. *This is a travel role that requires on-site visits to participants homes. Duties for this position include but are not limited to: - Participate and provide research nurse services to qualified study participants at home - Apply clinical research and nursing practices to develop solutions to complex problems - Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support - Participate in activities that will further the operational development of Science 37 nursing service delivery - Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes - Other duties as assigned as the needs of Science 37 evolve and change This position has the following qualifications: - BSN degree preferred - Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change. - Active RN licensure in home state as well as eligibility for Compact Licensure required - Minimum 2+ years clinical/research experience preferred - Basic Life Support (BLS) Certification - Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings - Travel and availability qualifications are as follows: - 1-2 days minimum a week dedicated to support Science 37's study visits - Weekday/night availability required - Must be willing to travel to a participants homes - Active Driver’s License Science 37 is looking for people with the following skills and competencies: - BSN degree preferred - Active RN licensure in home state as well as eligibility for Compact Licensure required - Minimum 2+ years clinical/research experience preferred - Basic Life Support (BLS) Certification - Active Driver’s License - Weekday/night availability required - Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings - Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed - Ability to obtain nursing license in multiple states based on study needs - Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight - Access to a reliable vehicle to perform study participant visits and transport equipment - Ability to drive to local and/or remote locations to perform study participant visits - Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets - Ability to communicate in English (both verbal and written) There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group. Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate’s actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range. Science 37 is an equal opportunity employer. We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Submit your resume to apply! To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here

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 Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. *This is a Contract role with potential to convert to Full Time after 6 months* DUTIES AND RESPONSIBILITIES Duties include but are not limited to: - Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure. - Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required. - Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support. - Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials. - Collaborates with study investigators in determining eligibility of potential participants in clinical trials. - Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol. - Ensures research quality by practicing in compliance with and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. - Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents. - Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability. - In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. - Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. - Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. - Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to guidelines. - Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives. - Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations. - Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research. - Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management. - Provides process improvement solutions and collaborates on the implementation of the solutions. - Additional responsibilities may include working directly with other vendors and/or sponsors. - Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. - Provides mentorship and training for other CRCs as needed. - Provides assistance to and creates a supportive environment for the CRC team. DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS - Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager. - Develops project plan outlining planning, execution and closeout processes. - Develops the study communication plan in collaboration with the sites. - Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures. - Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution. - Other duties, as assigned. QUALIFICATIONS & SKILLS Qualifications The following qualifications are preferred and/or equivalent applicable experience: - Bachelor’s degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the assigned duties and responsibilities. Advanced degree preferred but not required. - A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field. - ACRP (CCRC) or SoCRA (CCRP) certification, highly desired - Medical and scientific knowledge, preferred. - Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements. - Excellent time management, organizational skills and ability to manage multiple tasks. - Attention to detail and accuracy in work. - Must have the ability to conduct collaborative interaction with cross functional team members. Skills/Competencies - Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through. - Expert Knowledge of FDA regulations and GCP guidelines – Understands applicable regulations and implications for trial participation. - Expert knowledge of clinical research - Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. - Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant rapport, project team members, and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner. - Leadership skills - Demonstrates the ability to communicate effectively across multifunctional teams. Provides effective solutions to challenges. Is recognized by others as a leader and a resource. - Computer skills - Proficient with MS Office and Google Suite applications. Able to generate business correspondence, create forms and generate spreadsheet reports as required. Demonstrates expertise in the use of proprietary software. - Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making. Capabilities - Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed - Ability to communicate in English (both verbal and written) - May require extended or unusual work hours based on research requirements and business needs. 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. Submit your resume to apply! To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here

• Function as the Principal Investigator for clinical trials • Function as a Sub-Investigator for clinical trials • Coordination with Site Operations Manager to identify, onboard and train investigators • Educate and train Science 37 study team about target patient population • Collaboration with Business Development counterpart to review study opportunities • Support Science 37 study opportunities as a subject matter expert • Collaborate with Science 37 Regulatory Affairs team to engage the FDA • Serve as Science 37 representative for decentralized clinical trial

• Function as the Principal Investigator for clinical trials when Science 37 is executing studies. • Function as a Sub-Investigator for clinical trials. • 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. • Collaboration with Business Development counterpart to review study opportunity synopses/protocols. • Support Business Development counterpart during sponsor/client meetings and teleconferences. • Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies. • Work with sponsors/collaborators to identify clinical endpoints. • Serve as Science 37 representative for decentralized clinical trial and therapeutic area-specific expertise. • Publish peer-reviewed articles and white papers related to therapeutic area-specific expertise.

Role Description 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 - 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. - 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. - 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. - 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 - 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. Submit your resume to apply!