Senior Clinical Lead, Early Clinical & Experimental Therapeutics

About the role

Join the engine of Sanofis 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.

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.
• Maintain effective collaborations with investigators and other external experts.
• Present data at appropriate meetings (inside or outside Sanofi).

Requirements

• 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

Qualifications

• 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

Skills

• MD + PhD (or analogous bench science experience) strongly preferred
• Experience in global pharma setting
• Medical and/or Scientific experience with combination therapies and drugs targeting cytoplasmic signaling pathways
• Postgraduate residency training and laboratory research (see above) in industry or academia
• Experience in the conduct of late phase clinical trials

Benefits

Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pay

Commensurate with demonstrated experience.

Schedule

N/A