Sanofi is one of the main players in the Pharmaceutical industry, with a presence in the Vaccines, Consumption, and Primary & Specialty Care markets.
Do you want to change the lives of patients? Is innovation part of your way of working? Are you passionate about transformation and being a leader in change?
The Medical Advisor position reporting to the Americas CSU MDA Head provides Medical and Scientific leadership and support to the Project Management and other CSU teams in the South Cone Cluster CSU.
MAIN SUPERVISED RESOURCE
Medical Training Programs
Assess the feasibility of international protocols in his / her country by collecting information and documentation on the study to be performed and by conducting surveys with opinion leaders or potential investigators according to GBU / Medical Affairs requirements.
First-line medical support to the CSU team e.g. : answer medical questions from investigating sites, study teams, answer questions from Ethics Committees, Health Authorities.
Ensure scientific training for the monitoring team.
Maintain and expand the investigator network in his / her country.
Contribute to the exchange of relevant information between R&D and Medical Affairs / Business Unit stakeholders regarding the clinical activity of the CSU and support the handover of R&D products to marketed compounds.
CSU preferred point of contact for GBUs to provide input on Clinical Development Plan and medical practices (e.g. review of an extended synopsis, protocol amendments).
Protocol review and validation of translation ( e.g. : ICF, protocol)
Work in close collaboration with the SPM team to identify and develop a partner site network
Develop and maintain close collaboration with the Digital team (CI and tools), PAG, MSLs to identify sites and investigators for early involvement in protocol review and site identification in a sustainable manner.
Inside the company :
Patient Advocacy group
Outside the company :
Investigators and Key Opinion Leaders
MAJOR CHALLENGES OF THE POSITION
Support the conduction and development of all clinical studies managed within the CSU
Identify KOL, potential investigators and partner sites for CSU clinical studies
Identify the weaknesses and strengths of a study : design, inclusion / exclusion criteria, endpoints, safety, and efficacy
Assertive evaluation in collaboration with CSU Head of upcoming studies taking into account the following considerations as an example : epidemiology, competitive environment, approval timelines in the country, site performance.
Forming a strong network with local potential investigators. Contributing local scientific knowledge and lobbying allowing country-specific information on competitive intelligence and validation of global hypothesis from the CDP.
Liaise with local Medical Affairs within Sanofi to manage investigators and compounds.
Ability to navigate and communicate in a highly matrixed environment
Able to analyze data for feasibility, site identification, enrollment projections, and competitive intelligence
Previous clinical experience (3yrs)
Previous experience in Clinical Research, management of clinical trials (3yrs)
Knowledge in local regulations
Specialization in internal medicine and / or clinical pharmacology and / or relevant medical discipline.
MAJOR SKILLS AND COMPETENCES
Excellent communication skills and interpersonal relations
Able to organize large volumes of work
Able to travel
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.