• Job Description

  Req#: 390666BR
  Disease Area: Oncology
  Remote Position
  
  The Associate Clinical Research Medical Director provides clinical strategic and tactical leadership in the country to support GDD trials and selected NIBR trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents.
  •Closely collaborates with the Trial Monitoring Organization 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 meetings, 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 leverage the value of the assigned project(s) in the context of the investigational product(s).
  •Drives implementation of innovative ways running clinical trials
  
  Major Accountabilities:
  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 Organization to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment 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 CPMs, and other functions in the country as needed
  •Provide protocol, Risk management plan & disease training as appropriate, and externally at Investigator’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 medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, 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 when translated into the local language, including the patient narrative where appropriate
  •Support Ministry of Health interaction (or local Board of Health) as needed
  •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.
  •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:
  o Provide medical expertise support to pharmacovigilance activities
  o Responsible to review the medical aspects of clinical trial SAEs occurring in the country and support patient safety team, if needed
  o Follow-up with the Investigator for additional information or clarifications as needed
  o 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 Regional/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 to support and improve processes for the CD&A/CRMA Line function
  •Support safety and peer to peer clinical expertise discussions that are under the role of the MD
  
  

• About the company

  At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...

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