Major Challenges and opportunities:
 

• Spokesperson of TMU and Clinical Patient Sciences; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative mindset.
• Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.
• Ensure Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.
• Ensure high quality documents, requiring strong writing and communication skills.
• Manage aggressive timelines effectively through cross-functional planning.
• Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety, information for Regulatory authorities.

Key Internal/External Relationships:

• Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups.
• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

At the clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM principal duties and responsibilities include:

Study preparation:

• Design and conduct early clinical development studies including phase 2a within planned timelines (supported by an operational team).
• Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).
• Coordinate clinical team to set-up and follow the study.
• Ensure proper documentation is provided to the Ethics Committees and Health Authorities.
   

Study conduct:

• Ensure that the study is scientifically sound and correctly conducted.
• Prepare and review the interim investigator reports.
• Lead the Dose Escalation Meeting and document decision making (for First-in-Human studies).
• Review the Adverse Event reports.
   

Study validation and reporting:

• Participate in the data review and validation meetings before database lock.
• Review and interpret the results.
• Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.
   

Key Internal/External Relationships:

• Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups.
• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

About you

Skills that you have (mandatory)
 

Experience:

• Experience in basic science, translational medicine and/or clinical research

Soft and technical skills:

• Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Demonstrated capability to challenge decision and status quo with a risk-management approach
• Ability to work within a matrix organization, within CPS, TMU, R&D and beyond e.g. Medical.
• International/ intercultural working skills
• Open-minded to apply new digital and/or AI-driven solutions.

Education:
Mandatory Qualifications:

• Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience
• Broad immunology, neurology and/or ophtalmology knowledge base
• Knowledge and mindset in translational research
• Able to acquire and apply new technical skills

Languages: fluent in English.

Nice to have Qualifications:

• Postgraduate residency training; laboratory research in industry or academia is a plus.

Skills that you could offer in addition (nice to have)

• Experience:

• Knowledge and mindset in translational research.

• Experience in the conduct of late phase clinical trials.

Why choose us?

• Chase the miracles of science to improve people’s lives, alongside a supportive, future-focused team to speed up drug development.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Join the newly formed Translational Medicine Unit organization globally responsible for translational activities across R&D.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€101,040.00 - €134,720

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.