R&D - TMU - Clinical Lead, Early Clinical & Experimental Therapeutics - SH

Job title:Clinical Lead, ECET

• Location: China

• Grade: L4-1

• Hiring Manager: TMU Head, China

About the job

This position located within the Translational Medicine Unit (TMU) China Team to support the Global Early Clinical and Experimental Therapeutics (ECET) Oncology Team. This role work with the global asset team 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 in China

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 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.  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.

Main responsibilities:

At the project level, the Clinical Lead, ECET Oncology China 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 iincluding 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 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.

• 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

• Oversight of 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 writing and communication skills.

• Manage aggressive timelines effectively through cross-functional planning.

• Maintain effective collaborations with local KOLs/PIs

• 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), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups.

• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, 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.

• Ensure 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.
  

Key Internal/External Relationships:

• Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups.

• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

About you

Skills and Education that you have (mandatory)

Mandatory Education Qualifications:

·       Advanced degree: M.D. or M.D./Ph.D.

Mandatory Experience:

·       Minimum 2-5 years of clinical research experience

·       Demonstrated 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.

·       Demonstrated experience leading cross-functional teams

·       Experience working with CROs

·       Experience providing Medical Safety oversight for clinical trials

·       Experience participating in design and interpretation of translational/biomarker research

·       Experience using emerging digital/AI-driven tools and solutions

Mandatory Skills:

·       Broad biomedical knowledge base

·       Demonstrated knowledge of GCP practices

·       Able to acquire and apply new technical skills

·       Documented excellent communication skills (verbal and written) for global interactions across functional areas, CROs, and for interactions with key regulatory agencies

·       Demonstrated capability to challenge decision and status quo with a risk-management approach

·       Ability to work within a matrix organization, within TMU, CPS, R&D and beyond e.g. Medical.

·       International/ intercultural working skills

• External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

Mandatory Languages

·       Fluent in Mandarin, English.

Skills and Education that are nice to have

Nice to have Qualifications:

·       Experience in global pharma setting

·       Postgraduate residency training: laboratory research in industry or academia

·       Experience in the conduct of late phase clinical trials