Clinical Lead Early Clinical and Experimental Therapeutics Oncology

Job description

Job title: Clinical Lead Early Development and Experimental Therapeutics - Oncology Location: Cambridge, MA or Morristown, NJ About the job 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. This role 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 key member of asset Global Project Teams, Translational Medicine Subteams 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 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. Operationally, this role will coordinate work by regulatory, safety/pharmacovigilance, biostatistics, biomarker and PK, and clinical operations, including oversite 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. 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. About Sanofi We’re 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. Main Responsibilities: At the project level, the Clinical Lead, ECET Oncology will be a member of the asset Global Project Team and the Translational Medicine Subteam. In these roles, duties include: 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 At the clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM principal duties and responsibilities include: Study preparation: Design and conduct early clinical development studies FIH to phase 2a within planned timelines (supported by an operational team). Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.). Coordinate clinical team to set-up and follow the study. nsure proper documentation is provided to the Ethics Committees and Health Authorities. Study conduct: Ensure that the study is scientifically sound and correctly conducted. Coordinate oversight of CROs or outsourced activities Coordinate cross-functional communication and cooperation Prepare and review the interim investigator reports. Lead the Dose Escalation Meeting and document decision making (for First-in-Human studies). Review the Adverse Event reports. Oversight of safety monitoring Study validation and reporting: Participate in the data review and validation meetings before database lock. Review and interpret the results. Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report. About you Minimum Education Required: M.D. or equivalent Minimum Experience Required 3 years of clinical research experience Mandatory Languages: English Preferred Qualifications: MD + PhD ( or analogous bench science experience) strongly preferred. Experience overseeing patients in 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