[Key Responsibilities 담당업무]

 Support Study Director of Clinical Development with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs,

   Responsible for analytic support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting,

   and providing preliminary assessments and recommendations to Chief Medical Officer.

   Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety

 Responsible for scientific leadership, design, analysis and reporting for all phase-appropriate and registrationenabling DMPK studies

   (e.g., bioavailability, ADME, bioequivalence, DDI, food-effect, PKPD modeling)

 Work with cross-functional team with oversight by the Chief Medical Officer to conduct clinical studies, including clinical, pharmacokinetics

   and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans

   (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports,

   and study close-out activities

 Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents under the direction of the Chief Medical Officer

 Interact with internal and external stakeholders (study sites, vendors, committee etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations

 Represent MedPacto to outside personnel in the development of clinical protocols and study conduct

 Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team

 Prepare literature review as needed

 Support preparation of Scientific material for conference presentations or publications

 Collaborates with cross-functional teams for assigned studies



[Qualification Requirements, 지원자격]

 Life Science degree (preferred PhD or Master in Biomedical sciences and related academic field) with 2~3+ years of clinical or pre-clinical research experience

   in the pharmaceutical of healthcare setting

 Experience in analysis and interpretation of clinical data (pharmacokinetics, safety and efficacy); working knowledge of biostatics, GCP, and regulatory requirements

   for clinical studies.

 Excellent oral and written communication skills and solid computer/analytical skills

 Ability to work collaboratively with agility, team-based matrix environment and to function independently as appropriate

 Project management skills

 Ability to handle multiple projects as a time and have a strong attention to detail while understanding the higherlevel strate