Senior Clinical Lead, Early Clinical & Experimental Therapeutics

Job title
:
Senior Clinical Lead, Early Clinical & Experimental Therapeutics

Location
:
Cambridge, MA / Morristown, NJ

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

This is an exciting opportunity to address unmet needs in oncology by developing an inhibitor of a key signalling pathway as monotherapy and in potential combination with agents of varied modality. The successful candidate will also help translate a portfolio of preclinical assets into human studies.

The position falls within the Translational Medicine Unit (TMU) Clinical Patient Services (CPS) Team to support the Global Early Clinical and Experimental Therapeutics (ECET) Oncology Team. It works within global asset teams to design and lead early clinical development of oncology assets such as small molecules, monoclonal antibodies, antibody drug conjugates and immune cell engagers, for solid tumors or hematologic malignancies.

This position will be responsible for the early clinical development of RAS-associated pathway inhibitor(s), as well as some pre‑clinical assets.

In addition to being an integral part of the Oncology ECET Team, the individual in this position is a key member of asset Global Project Teams, Translational Medicine Sub‑teams and Development disease area teams from preclinical development through phase 2a. A key focus of this role is to support 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 to Human Target Validation (HTV) and evaluating 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 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.

Operationally, this role will coordinate work by regulatory, safety/pharmacovigilance, biostatistics, biomarker and PK, and clinical operations, including oversight of CROs. The ability to integrate the outputs of multiple disciplines into a coherent translational medicine and human target validation plan and successful clinical trial is essential.

We are an R&D‑driven, AI‑powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

• 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 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…