R&D - Associate Clinical Research Director - SH

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

• Copperate with strong, independent technology group and experience digital & innovative ways of working
• Be viewed as a trusted partner, shared goals and quality work

What you can contribute?

The role of the Associate CRD is to:

• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
• Contribute to the Extended synopsis and Protocol for their project
• Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

Key responsibilities include:

• Develop the abbreviated protocol
• Develop the final protocol and protocol amendments
• Medical support to clinical operation team during the clinical feasibility
• Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
• Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
• Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
• Participate in the elaboration of training material and presentations at the investigator meetings
• Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO
• Answer to medical questions raised by EC/IRBs, sites
• Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
• Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:
  • feasibility managers for feasibility preparation and validation of feasibility results
  • Medical Writers to develop, review and finalize WSIs, study protocols and reports
  • Clinical Scientists, Medical review team and Coding
  • Pharmacovigilance (GSO, CME)
  • CTOMs, Biostatisticians
  • CSU medical advisors for the best knowledge of the study, compound, protocol
  • TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs
  • CROs
  • Regulatory affairs
• Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the global project head and clinical lead
• Provide operational expertise to project clinical sub team, as needed

What you should have?

• Medical Doctor (MD) preferred: Pediatrician, Neurologist, Hematologist
• English fluent (spoken and written)
• At least 3 years in pharmaceutical industry or CRO, previous experience in clinical development
• Understanding of pharmaceutical product development and life cycle management gained through preferably ~3 year of development and / or medical / clinical experience
• Good Scientific and medical expertise
• Good knowledge / expertise in clinical development and methodology of clinical studies
• Fluency in written and spoken English

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

• Good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Ability to work within a matrix model
• Open to work in an international and intercultural environment
• Open-minded to apply and learn digital solutions