Senior Clinical Lead, Early Clinical & Experimental Therapeutics

Sanofi•Morristown, MA

9d•Onsite

About The Position

This position is 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.

Requirements

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
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

Nice To Haves

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

Responsibilities

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.
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.
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).
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.
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
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.