More jobs:
Clinical Lead, Early Clinical and Experimental Therapeutics
Job in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2025-11-27
Listing for:
Sanofi
Full Time
position Listed on 2025-11-27
Job specializations:
-
Doctor/Physician
Medical Doctor
Job Description & How to Apply Below
* 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 as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions and other 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 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.
* Present data at appropriate meetings (inside or outside Sanofi).
* Present data at appropriate meetings (inside or outside Sanofi).
* Spokesperson of TMU and Clinical Patient Sciences; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative mindset.
* Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.
* 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.
* Decision Making Authority:
Make front-line decisions on protocol design, execution, dose escalation and safety, information for Regulatory authorities.
* Knowledge and mindset in translational research.
* Experience in the conduct of late phase clinical trials.
** Education and Training**:
* Advanced degree: M.D. or M.D./Ph.D with at least 1-5 years of research experience
* Postgraduate residency training; laboratory research in industry or academia
* Broad biomedical knowledge base
* Knowledge and mindset in translational research
* Able to acquire and apply new technical skills
** Soft and technical skills**:
* Very good communication skills (verbal and written) for interactions across functional areas 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 CPS, TMU, R&D and beyond e.g. Medical.
* International/ intercultural working skills
* Open-minded to apply new digital and/or AI-driven solutions.
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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