【Job Description】
• To provide clinical strategic and tactical leadership in the country to support GDD trials, clinical de-velopment plans which change the world, concept sheets/protocols and other clinical documents
• To provide country clinical strategic guidance and feasibility assessment for NIBR PoC trials
• Closely collaborates with the Trial Monitoring Organisation and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan
• May lead medical/clinical discussion with local regulatory interactions as needed (CTA, NDA meet-ings, label discussions, post-approval commitments etc.)
• Cooperates with local functions such as e.g. Medical Affairs, Patient access to identify and involve qualified investigators with recruitment potential and relevant key experts for clinical development in order to exploit the value of the assigned project(s) in the context of the investigational product(s).

【Your key responsibilities】
Provide clinical development and indication expertise specific to a country and drives together with the local TMO organization execution of clinical trials with high quality and in planned timelines:

• Closely collaborates with the Trial Monitoring Organisation to ensure fast clinical trial start up, re-cruitment according to planned timelines, early identification of potential delays and robust re-cruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
• Provides robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed
• Provide protocol, Risk management plan & disease training as appropriate, and externally at In-vestigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medi-cal practice using physician interviews, local databases (RWE, payer data, patient association feedback, etc.) and analysis of the competitive environment
• Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions
• Review country or site specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials /NIBR PoC studies when translated into the lo-cal language, including the patient narrative where appropriate
• Support Ministry of Health interaction (or local Board of Health) as required

Provide clinical development and indication expertise specific to a country and drives together with the local TMO organization execution of clinical trials with high quality and in planned timelines:

• Closely collaborates with the Trial Monitoring Organisation to ensure fast clinical trial start up, re-cruitment according to planned timelines, early identification of potential delays and robust re-cruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
• Provides robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed
• Provide protocol, Risk management plan & disease training as appropriate, and externally at In-vestigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medi-cal practice using physician interviews, local databases (RWE, payer data, patient association feedback, etc.) and analysis of the competitive environment
• Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions
• Review country or site specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials /NIBR PoC studies when translated into the lo-cal language, including the patient narrative where appropriate
• Support Ministry of Health interaction (or local Board of Health) as required
• Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials and NIBR PoC trials.
• Support planning, implementation and follow-up of regulatory agency inspections and internal audits
• Review and resolution of local medical issues / questions – if necessary support the discussion of issues to global teams.
• Perform local AE review for development compounds and provide general medical support for safety issues:
- Provide medical expertise support to pharmacovigilance activities
- Responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed
- Follow-up with the Investigator for additional information or clarifications as needed
- When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc
• May be called upon to provide clinical/medical strategic and tactical input into clinical development plans and protocol designs at a global level. May also serve as Country representative in Region-al/Global feasibility team. Identify high quality local/regional datasets (e.g. registries etc) which could be used to drive innovative study designs or support recruitment
• Drive all scientific activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and local regulations
• Participation in Early product planning process to ensure that TMO trials conducted optimize cross-functional country strategy
• Participate in global working groups in order to support and improve processes for the CD&A/CRMA Line function