Clinical Lead, Early Clinical and Experimental Therapeutics

Role Summary

Clinical Lead, Early Clinical and Experimental Therapeutics. Location: Cambridge, MA; Morristown, NJ.

Responsibilities

• Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating into the overall development strategy in collaboration with the responsible Therapeutic Area in research and development.
• Design safe, rapid and informative First-In-Human studies including First In Patients, 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.
• Supervise the execution and ensure close 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.
• Present data at appropriate meetings (inside or outside Sanofi).

Qualifications

• Mandatory Qualifications:
  • Solid Experience in the design and execution of early development clinical trials (phase 1a/b and 2a) and exploratory studies in pharmaceutical industry and/or in academic institution/hospital and/or in clinical site/CRO.
• Nice To Have Qualifications:
  • Knowledge and mindset in translational research.
  • Experience in the conduct of late phase clinical trials.

Education

• Mandatory Qualifications:
  • Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience
  • Postgraduate residency training; laboratory research in industry or academia
  • Broad biomedical knowledge base
  • Knowledge and mindset in translational research
  • Able to acquire and apply new technical skills
• Nice To Have Qualifications:
  • M.D./Ph.D. strongly preferred

Skills

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

Additional Requirements

• Languages: fluent in English.