Clinical Lead, Early Clinical and Experimental Therapeutics

Sanofi • Morristown, NJ

93d • $201,000 - $290,333

About The Position

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our state-of-the-art ECET department as a Clinical Lead, ECET and you'll drive the translation between preclinical development through early clinical development and beyond, while enjoying lots of opportunities to broaden your experience and hone your skills. This position located within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS) / Early Clinical and Experimental Therapeutics (ECET) is responsible for ECET contributions across all therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, gene therapy including nucleic acid modalities. The individual in this position is an integral part of the therapeutic area project teams and cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical development including early and rapid Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute building the Human Target Validation (HTV) and to evaluate the pharmacology of novel therapeutic approaches. Additionally, to identify potential signals of efficacy or safety notably for new indications and gain better understanding on the mode of action, signal seeking clinical and mechanistic trials are in the scope of expertise for this role. Collaborative interactions with research scientists, toxicologists, pharmacokineticists, modelling & simulation experts, biomarker experts, and late phase therapeutic area clinicians are critical to success in the role. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine and human target validation plan is essential.

Requirements

• 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.
• 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 Haves

• Knowledge and mindset in translational research.
• Experience in the conduct of late phase clinical trials.
• M.D./Ph.D. strongly preferred.

Responsibilities

• Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating into to 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).

Benefits

• High-quality healthcare.
• Prevention and wellness programs.
• At least 14 weeks' gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees