This role is key for medical supervision and medical management of clinical trials in the country. The Medical Advisor (MA) is the medical link between CSU, local medical or regulatory affiliates, Medical Operations (and / or Units / Customers) and (potential) investigators or experts / KOLs in the country.
He / She offers medical support to CSU team in the therapeutic areas for the studies he / she is allocated to. He / She provides appropriate medical feedback to central clinical trial team especially to Clinical Study Director (CSD) and Global Feasibility Lead (GFL).
Medical liaison and collaboration with the global team (CSD, GFL, )
Performing Feasibility or Pre-Assessment of studies
Building and keeping strong network with local potential and actual investigators
Providing expert scientific advice on assigned product(s) and therapeutic area(s)
Keep updated on 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 Extended Synopsis (ES) / protocol contents
Liaising with local Medical Affairs within sanofi to manage investigators and compounds.
Providing medical input to local or regional study teams, for local, regional and global protocols and support to Health Authorities / Ethics questions / interactions
Providing Medical Training to CSUs.
a. General Activities
Feasibility & investigators network
Conduct pre-assessment and / or feasibility of trials protocols in the country 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) requirements and timing.
Promote participation of the country / cluster / region at clinical studies, according to country / cluster / region strategy.
CSU preferred point of contact for Medical Operations, contributing with specialist medical knowledge to review and to provide medical input on proposed ES, protocol and / or Clinical Development Plan and medical practices / treatment guidelines in the country / cluster / region.
Maintain and expand the investigator network in the country
Support the affiliates’ network of Key Opinion Leaders (KOLs) and experts when selecting National Coordinators or members of Study Committees (in the selection of such individuals Med Advisor must assess the true potential contribution of these individuals).
Support to clinical operations
First-line medical support to the CSU team e.g. lead the answering of medical questions from investigative site, Ethics Committees, Health Authorities, monitoring teams (MTs), study mangers (including also appropriate interaction with CSD and global team).
Provide medical & scientific training to the monitoring team and other CSU members (according to CSU training plan) includes support for good understanding of materials provided by Global team when required.
Ensure quality of local / regional Investigator Meetings regarding medical content, ethics and interactions with investigators.
For selected studies, or when requested by MT : Conduct appropriate review of patients data (e.g. patients profiles, e-
CRF data ) especially for critical cases (outcome events, related SAEs, AEs with pre-specified monitoring, ...) in order to support MT and SO and achieve data quality.
Act as the medical expert supporting the Pharmacovigilance team including review of annual safety reports.
Collaborate with MT to ensure achievement of country / cluster or region study objectives, such as :
Recruitment target, especially for medical aspect of the patients recruitment strategy. Motivation visit to the sites (i.
e. to boost recruitment) - CRO interactions
Validation of translations (i.e. : Protocol, ICRF, amendments, I Brochure, etc) where applicable.
Communication with sanofi medical affairs , regulatory affairs and external medical community
Collaborate with medical affairs, regulatory affairs and related stakeholders on clinical activity strategy development
Contribute to the exchange of relevant information between R&D and Medical Affairs regarding clinical activity of the CSU and support the handover of R&D products to marketed compounds.
Maintaining relationships with internal and external specialists, including external and global interest groups, as well as establishing initial contact with KOLs and specialists in new indications.
Representing the CSU at scientific conferences / congresses, introducing / presenting the CSU at local / international investigator meetings, meeting with interest groups for specific diseases, Pharma association, scientific societies.
Providing important medical information for investigators and specialists according to the communication strategies (i.e.
study results, study termination etc). Related to clinical studies managed by the CSU.
Develop or supervise development of protocol and other study documents, such as CSR, publication manuscript for local medical affairs studies.
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