Reporting to the CMO, with a dotted line report to the VP of Clinical Operations, the Medical Director will lead the medical oversight of the clinical studies and ensure subject safety, site medical compliance with protocol and ICH-GCP requirements, and overall scientific integrity and quality of the clinical studies in the US. Additionally, the successful candidate will be responsible for the day-to-day Drug Safety function with the primary responsibility of providing medical and safety support to the activities associated with expedited and periodic safety reporting for both investigational and marketed products in the US.

Responsibilities:

• Proactively provide the medical leadership and scientific input to improve the project quality in the function of medical science, pharmacovigilance, clinical operation, data management, etc.

• In the area of medical science and clinical operation, MM should try to cover the following activities:

• Clinical and scientific expertise in the clinical trial protocol development process
• MMP/SMP development
• Medical support for monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning
• Medical assessment of subject eligibility
• Review of protocol deviations & conduction consistency in medical compliance of the protocol
• Medical training of TA, protocol, and other medical relative topics, etc.

• In the area of pharmacovigilance and data management, MM should try to cover the following activities:
  • Responsible for medical review of serious adverse events and non-serious adverse event in support of drug safety activities for clients.
  • Medical review of assigned cases to include review of narrative, coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious).
  • Perform weekly review of non-serious line listings for potential upgrades to serious and provide medical guidance to triage staff.
  • Write medical query and similar event analysis and provide causality assessment for individual case.
  • Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, DSUR and RMP) in terms of product safety profile.
  • Provide assessment of safety issues arising in clinical trials and escalate those to the line manager within the organization or/and client.
  • Review and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project.
  • Review and provide input to the Project Specific Procedures and participate in project related meetings.
  • Communicate with the client to an extent as described in the Project Specific Procedures.
  • Provide assistance in the preparation and conduct of coding convention.
  • Potentially, provide support to the site support (call), including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
  • Involve in the SAE reconciliation between the clinical database and the safety database
  • Lead the IDMC review and signal detection analysis

• Departmental Management Responsibilities:
  • Lead department to identify Medical Monitor/ Medical safety assessment process needs and areas for improvement.
  • Lead in the development of department or cross functional SOPs, policies and working guidelines.
  • Manager employee associated with MM/MSO, assign and coordinate projects within the department
  • Be responsible for the internal training courses related to MM/MSO. Provide on-job training to MM/MSO.