Clinical Lead, Early Clinical and Experimental Therapeutics

About This Role

Drive the translation between preclinical development through early clinical development and beyond as a Clinical Lead within the Early Clinical and Experimental Therapeutics department. This role contributes to building Human Target Validation and evaluating the pharmacology of novel therapeutic approaches across various modalities.

Responsibilities

• Participate in designing the early development plan and overall ECET plan for clinical development steps, integrating into the overall development strategy.
• 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.
• Supervise the execution and ensure close medical monitoring of studies.
• Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, and study reports.
• Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaise with partners on projects.
• Participate in dose selection for First-In-Human studies and drive Go/No Go decisions when needed.
• Ensure an adequate follow-up of studies and project timelines.
• Present data at appropriate internal and external meetings.
• Serve as Study Medical Manager (SMM) for selected clinical studies, including designing and conducting early clinical development studies.
• Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).

Requirements

• Advanced degree: M.D. or M.D./Ph.D.
• At least 1-5 years of research experience
• Postgraduate residency training and/or laboratory research in industry or academia
• Solid experience in the design and execution of early development clinical trials (phase 1a/b and 2a) and exploratory studies
• Broad biomedical knowledge base
• Fluent in English

Qualifications

• M.D. or M.D./Ph.D with at least 1-5 years of research experience
• 1-5 years of research experience with an M.D. or M.D./Ph.D; Solid 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.

Nice to Have

• Knowledge and mindset in translational research
• Experience in the conduct of late phase clinical trials
• M.D./Ph.D. strongly preferred

Benefits