Medical Advisor (MA) and CSU Safety Lead Back up at Sanofi

JOB PURPOSE:

• This role is key for medical supervision and medical management of clinical trials in various countries, clusters and across the region. The Medical Advisor (MA) is the medical link between Medical Operations (and/or Units/Customers) and (potential) investigators or experts/KOL in cluster countries.
• He/she should be the medical support in the territory for the studies he/she is allocated to.
• He/she should provide appropriate medical feedback to central clinical trial team especially to Clinical Study Director (CSD) and Global Feasibility Lead (GFL)
• To better serve some customers (Oncology, Diabetes, …), qualification in a medical specialization will be required or at least appreciated.
• Participation to CSUs management and CSU Orientation/Induction Program
• Provide medical input to local or regional study team(s).
   

KEY ACCOUNTABILITIES:

• Conduct pressure tests and/or assess the feasibility of international protocols in his /her country(ies) by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders, experts or potential investigators and Health Authorities according to Clinical Study Director (CSD) and Global Feasibility Lead (GFL) in CSO and Medical Operations requirements and timing.
• May from time to time when selected, assume Regional Medical Advisor role (ad-hoc basis when required) with responsibilities as follows:
   
  • “Medical” liaison and collaboration with the global team (CSD, GFL, MA’s from other regions…)
  • Commitment to perform (regional) pre-feasibility studies in liaison with other MA’s from other regions and relevant team members, in order to provide robust and reliable feedback.
  • Contribution to reliable and sound study documents (concept protocol and amended protocol).
  • Strong network with local and international potential investigators (KOLs) as well as Premier and Partner sites.
  • Provide expert scientific advice and leadership while managing a broad range of activities associated with the assigned product(s) and therapeutic area(s).
  • Local scientific knowledge and lobbying allowing capture of country specific information on competitive intelligence and validation of global hypothesis from the Clinical Development Plan or assessment of Study ID card /protocol contents,
  • Liaise with Medical Affairs (local and international) to manage investigators and compounds during pressure tests when required.
  • Provide medical input to local or regional study team(s)
     

• CSU preferred point of contact for Medical Operations to review and to provide medical input on proposed Study ID card, protocol and/or Clinical Development Plan and medical practices in countries, cluster or region.
• Promote participation of the country, cluster or region for any clinical study and maintain and expand the investigator network in his/her country.
• Support the affiliates network of KOL and experts when selecting National Coordinators or members of Study Committees.
• First-line medical support to the CSU/Clusters team e.g.: lead the answering medical questions from investigating sites, Ethics Committees, monitoring teams (MTs), study managers and appropriate interaction with CSD and global team.
• Ensure medical & scientific training to the monitoring team and others (including good understanding of material provided by the Global team (e.g; Firecrest modules, …).
• Ensure quality of local/regional Investigator Meetings regarding medical content, ethics and interaction with investigators.
• Conduct appropriate review of patients data (e.g. patients profiles, e-CRF data, …) especially for critical cases (outcome events, related SAEs, AEs with prespecified monitoring, …) in order to support MT and CSO and achieve data quality.
• Contribute to the exchange of relevant information between R&D and Medico- Marketing department regarding clinical activity of the CSU/Cluster and support the handover of R&D products to marketed compounds.
• Interaction with stakeholders such as Clinical Study Directors and Global Feasibility Leads of the CS&O Platform or physicians in affiliates should be driven by collaboration and team spirit in a medical, scientific and ethical approach.
• Needs to argue on local considerations, constraints when respecting regional or worldwide standardized approach.
• Good relationship with external experts allowing accurate knowledge of local medical practice, standard of care.
• Assume the role of Clinical Study Unit Safety Lead Back up (CSU-SL Back up) in the absence of the designated Clinical Study Unit Safety Lead (CSU-SL).
• The Clinical Study Unit Safety Lead Back up (CSU-SL Back up) is accountable for the oversight of defined Pharmacovigilance tasks and safety documentation and reporting of safety events (especially Serious Adverse Events and Adverse Events of Pre-specified Monitoring) related to clinical studies within her / his organization under the leadership of the Cluster Head, in absence of the CSU-SL.
• The CSU-SL (or CSU-SL back up) is the primary local contact for Global Pharmacovigilance (GPV) concerning Pharmacovigilance activities or matters in clinical studies.
• This role is key for supervision and management of all safety issues occurring in clinical trials performed in their country (ies). Consequently the CSU-SL (or CSU-SL back up) should work with the CSU Quality Lead and study teams to ensure appropriate training of the monitoring staff and with Medical Advisors for appropriate medical review of safety at country level.
• This relates to all clinical studies including phase IV, Bioequivalence and Bio-availibilty studies performed by the Clinical Sciences and Operations Platform in the country (ies).
• For studies contracted out by sanofi-aventis, CSU-SL activities and responsibilities will be carried out by the Clinical Research Organisation or according to the study specific Safety Data Exchange Agreement
• Perform pharmacovigilance tasks and safety documentation and reporting of safety events (especially Serious Adverse Events and Adverse Events of Pre-specified Monitoring) related to clinical studies within her / his organization under the leadership of the Cluster Head and according to local / corporate Quality Documents.
  
   

Core Competencies:

• Demonstrated ability to evolve in a complex environment
• Medical Leader with clear and effective communication, Interest and ability to teach
• Political savvy in a Global environment
• Demonstrated ability to evolve in a complex environment
   

Behaviour

• Setting ambitious objectives while knowing how to take risks
• Developing skills, training and enabling learning on the job
• Acknowledging the right to experiment and make mistakes
• Developing innovative solutions and ways of doing things
• Making decisions & driving necessary changes for performance
• Knowing how to deal with conflict
• Guaranteeing performance in the short, medium and long term, while respecting our values : Act for change;Cooperate transversally; Strive for results and Commit to customers
   

Knowledge & Skills:

• Customers (CSD, GFL, investigators, KOLs, MT, …) & quality focused
• Negotiation skills
• Effective management skills:
• Management of communication and Information.
• Medicine & Science as driven by GCP
• English - written & verbal proficiency
   

JOB-HOLDER ENTRY REQUIREMENTS :
Education:

• Medically qualified (Medical degree) and HPCSA registered
• Computer Literate: MS Word, MS Excel, Power Point
• ICH/GCP trained
   

Experience & Knowledge:

• Experience in Clinical Development or Clinical Research
• Demonstrated ability to evolve in a complex environment
• Negotiation skills
   

Sanofi IS AN EQUAL OPPORTUNITY EMPLOYER If you are interested in applying for this vacancy and you are confident that you meet the criteria set out in the advertisement kindly click on the link below