Senior Clinical Lead, Early Clinical & Experimental Therapeutics

About the role

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Main responsibilities

• Design safe, rapid and informative First-In-Human studies for oncology assets potentially including natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic studies.
• Participate in designing the plans for the different steps of clinical development, integrating these into to the overall development strategy in collaboration with the responsible Therapeutic Areas in research and development.
• Provide medical/clinical expertise and context to guide strategy for pre-clinical data generation and interpretation for oncology assets.
• Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety, information for Regulatory authorities.
• Supervise the successful execution of the clinical study/studies.
• Oversee and perform medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents.
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaises with partners on projects.
• Participate in the dose selection for First-In-Human studies, drive Go/No Go decisions when needed.
• Ensure an adequate follow-up of studies and project timelines.
• 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 communication skills.
• Manage aggressive timelines effectively through cross-functional planning.
• Maintain effective collaborations with investigators and other external experts.
• Present data at appropriate meetings (inside or outside Sanofi).

Key Internal/External Relationships

• Internal contacts: - Other TMU departments (Biomarkers and Precision Medicine, PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science)
• Bench research and toxicology colleagues to ensure target validation and asset suitability for clinical development
• Operations colleagues including Clinical Trial Managers and Data Managers
• Regulatory Affairs, Patients Safety & Pharmacovigilance, and Oncology Development Groups.
• External contacts: - Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, and clinical trial vendors
• Clinical and scientific experts, Key Opinion Leaders
• Ethics committees and Health Authority representatives.

About you

• Mandatory Education Qualifications: Advanced degree: M.D. or M.D./Ph.D.
• Mandatory Experience: Minimum 3 years of clinical research experience including both oversight of patients on early (Phase 1/2a) clinical trials and interpreting pre-clinical and biomarker data
• Experience in the design and execution of early development clinical trials (phase 1/2a) and exploratory studies in pharmaceutical industry and/or in academic institution/hospital and/or in clinical site/CRO.
• Demonstrated experience leading cross-functional teams (e.g. hospital care teams, research teams, etc.)
• Experience providing Medical Safety oversight for clinical trials
• Experience participating in design and/or interpretation of translational/biomarker research
• Experience using emerging digital/AI-driven tools and solutions
• Mandatory Skills: Application of broad biomedical knowledge to design and interpret nonclinical and clinical experiments
• Demonstrated knowledge of GCP practices
• Able to acquire and apply new technical skills
• Documented excellent communication skills (verbal and written) – appropriate to global interactions across functional areas, CROs, and with key regulatory agencies
• Demonstrated capability to challenge decision and status quo with a risk-management approach
• Ability to work within a matrix organization
• International/ intercultural working skills
• Mandatory Languages: English