Clinical Lead, Early Clinical and Experimental Therapeutics

Role Summary

Clinical Lead, Early Clinical and Experimental Therapeutics in Cambridge, MA and Morristown, NJ. Drives translation from preclinical development through early clinical development across multiple modalities (small molecules, antibodies, peptides, gene therapy) within the Translational Medicine Unit and ECET, contributing to Human Target Validation and pharmacology understanding to inform early go/no-go decisions.

Responsibilities

• Participate in designing the early development plan and overall ECET plan for steps of clinical development, integrating into the overall development strategy in collaboration with the responsible Therapeutic Area in research and development.
• Design safe, rapid and informative First-In-Human studies including First In Patients, natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism and Proof-of-Concept studies to provide robust data for early Go/No Go decisions and pharmacokinetic studies.
• Supervise the execution and ensure close medical monitoring.
• Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, study reports; some abstracts/manuscripts; clinical pharmacology or ECET components of investigator brochures and regulatory documents.
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on the assigned area and liaises with partners on projects.
• Participate in dose selection for First-In-Human studies, drive Go/No Go decisions when needed.
• Ensure adequate follow-up of studies and project timelines.
• Present data at appropriate meetings inside or outside Sanofi.

Major Challenges And Opportunities

• Spokesperson of TMU and Clinical Patient Sciences; maintain collaborative mindset.
• Address scientific challenges in early clinical development with inquisitiveness and proactivity.
• Maintain Clinical Trial standards at site and with other clinical functions; communicate effectively.
• Produce high-quality documents with strong writing and communication skills.
• Manage aggressive timelines through cross-functional planning.
• Make front-line decisions on protocol design, execution, dose escalation and safety information for regulatory authorities.

Key Internal/External Relationships

• Internal: Other TMU departments, EDCO, Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area R&D Groups.
• External: Investigators, Clinical Site Services Providers, early phase CROs, trial vendors, clinical/scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives.

Study Preparation

• Design and conduct early clinical development studies including phase 2a with an operational team.
• Review and approve study documentation (monitoring plan, SAP, contracts, regulatory documents, etc.).
• Coordinate clinical team to set up and follow the study.
• Ensure proper documentation to Ethics Committees and Health Authorities.

Study Conduct

• Ensure the study is scientifically sound and correctly conducted.
• Prepare and review interim investigator reports.
• Lead the Dose Escalation Meeting and document decisions for First-in-Human studies.
• Review Adverse Event reports.

Study Validation And Reporting

• Participate in data review and validation meetings before database lock.
• Review and interpret results.
• Prepare/distribute Key Results Memo and prepare/review Clinical Study Report.

Experience

About You

Mandatory Qualifications

• Solid experience designing and executing early development clinical trials (phase 1a/b and 2a) and exploratory studies in pharma industry or academia/institution/CRO.

Nice To Have Qualifications

• Knowledge in translational research.
• Experience in late-phase clinical trials.

Education And Training

• Advanced degree: M.D. or M.D./Ph.D with 1‚Äì5 years of research experience; postgraduate residency training; broad biomedical knowledge; ability to acquire/apply new technical skills.
• M.D./Ph.D. strongly preferred.

Soft And Technical Skills

• Excellent verbal and written communication across functional areas and with regulatory agencies.
• Risk-management mindset; ability to challenge decisions constructively.
• Ability to work in a matrix organization (CPS, TMU, R&D, Medical).
• International/intercultural working skills; openness to digital/AI-driven solutions.

Languages

English required.