Senior Clinical Lead, Early Clinical & Experimental Therapeutics

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.

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.

About you
Mandatory Education Qualifications:

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

Mandatory Experience:

Minimum 3 years of clinical research experience including both oversight of patients on 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 teams, research teams, etc.)

Experience providing Medical Safety oversight for clinical trials

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

Experience using emerging digital/AI-driven tools and solutions

Mandatory Skills:

Application of broad biomedical knowledge to design and interpret nonclinical and clinical experiments

Demonstrated knowledge of GCP practices

Able to acquire and apply new technical skills

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

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

Ability to work within a matrix organization.

International/ intercultural working skills

Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.

Mandatory Languages:

English

Preferred Qualifications:

MD + PhD ( or analogous bench science experience) strongly preferred

Experience in global pharma setting

Medical and/or Scientific experience with combination therapies and drugs targeting cytoplasmic signaling pathways

Postgraduate residency training and laboratory research (see above) in industry or academia

Experience in the conduct of late phase clinical trials