Non-clinical Drug Safety Senior Project Manager
il y a 18 heures
**Missions**:
- Optimize nonclinical development plans for products.
- Collaborate with project/asset teams to deliver optimized development plans.
- Handle non-clinical drug safety aspects in various documents (lB, CIA, IMPD, IND, Briefing documents, Expert reports).
- Contribute to non-clinical modules for submissions.
- Represent the nonclinical function during EU & US agency consultations.
- Identify external experts for issue resolution.
- Master a discipline within preclinical safety.
- Serve as a safety expert for “In or Out-Licensing” activities.
**EHS Responsibilities**:
- Comply with applicable EHS regulations and procedures.
- Report risks, malfunctions, or improvements related to EHS performance.
- Participate in mandatory EHS training.
**Education / Certifications**:
- Doctorate level in Toxicology (DVM, Pharm D, MD, or PhD).
- Board certification (ABT or ACVP) is a plus.
**Experience**:
- Minimum of 10 years in the pharmaceutical industry.
**Key Technical Competencies Required**:
- Strong scientific knowledge of toxicology (genotoxicity, reproductive toxicology, general toxicology, investigational toxicology).
- Ability to think transversally and understand factors influencing research and development.
**#LI-Hybrid**
LI-MC1
-
Sr. Clinical Development Director
il y a 6 jours
Les Ulis, France Ipsen Pharma (SAS) Temps pleinThe Senior Medical Development Director oncology is part of the Global Asset team responsible and accountable for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP)) as directed by the Vice-President Oncology Therapeutic Area Head in collaboration with the Asset Lead.It leads the Global...
-
Scientist Clinical Biomarkers
il y a 16 heures
Les Ulis, France IPSEN Temps plein**Title**: Scientist Clinical Biomarkers H/F **Company**: Ipsen Innovation (SAS) The clinical Biomarkers scientist will be responsible for successfully driving biomarkers activities, for multiple programs covering all three therapeutic areas (Oncology, Neuroscience, Rare Diseases), where needed. He/She will contribute to define biomarker plans for each...
-
Senior Project Manager Life Sciences
il y a 3 jours
Les Ulis, France Yseop Temps pleinYseop is recognized as the world-leading AI software company and pioneer in Generative AI. Yseop is the leader in Generative AI for regulated industries, changing the way content automation solutions are delivered with a human-centric, AI platform. Yseop is reimagining the future of scientific writing to get medicine into the hands of those who need it...
-
Senior Area Safety Officer
il y a 6 jours
Issy-les-Moulineaux, Île-de-France Kelly Science, Engineering, Technology & Telecom Temps pleinLocation:Issy-les-Moulineaux, France (Hybrid)Contract: 12 monthsKelly FSP is looking for a skilled Senior Area Safety Officer to join our client's team and drive compliance, risk management, and product vigilance across local, regional, and global levels.Your Impact:Ensure compliance with safety regulations and internal policies.Oversee product vigilance and...
-
Clinical Monitoring Lead
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Purpose of the position** - Take responsibility for coordinating the clinical monitoring activities, overseeing the CRO clinical /site management activities and co-monitoring the assigned international Phase I to III clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards...
-
Data Center Project Manager
il y a 4 semaines
Les Ulis, France Kelly Science, Engineering, Technology & Telecom Temps pleinData Centre Project ManagerLocation: Les Ulis, France (On Site)Contract: Full Time | Permanent or FTCRecruiter: Kelly FSP (on behalf of a global leader in IT infrastructure)Kelly FSP is partnering with a leading technology organisation to hire a hands on Data Centre Project Manager who will directly oversee the physical build out, installation, and...
-
Data Center Project Manager
il y a 2 semaines
Les Ulis, Île-de-France Kelly Science, Engineering, Technology & Telecom Temps pleinData Centre Project ManagerLocation:Les Ulis, France (On Site)Contract:Full Time | Permanent or FTCRecruiter:Kelly FSP (on behalf of a global leader in IT infrastructure)Kelly FSP is partnering with a leading technology organisation to hire ahands on Data Centre Project Managerwho will directly oversee thephysical build out, installation, and commissioningof...
-
Senior Project Engineer
il y a 3 jours
Les Ulis, France Kennametal Temps pleinAbout Kennametal With over 85 years as an industrial technology leader Kennametal productivity to customers through materials science tooling and wear-resistant solutions. Customers across aerospace and defense earthworks energy general engineering and transportation turn to Kennametal to help them manufacture with precision and efficiency. Learn more at ....
-
Manager Clinical Operations
il y a 2 semaines
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**Function** - R&D Operations **Sub function** - Clinical Trial Project Management **Category** - Manager, Clinical Trial Project Management (PL7) **Location** - Issy-Les-Moulineaux / France **Date posted** - May 28 2025 **Requisition number** - R-014717 **Work pattern** - Fully Onsite Description **Job Function**: R&D Operations ** Job Sub...
-
Global Clinical Monitoring Lead F/m
il y a 2 jours
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Main responsabilities** Ensure clinical activities coordination & oversight: - Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc ): to verify timely collection of essential study documents, such as regulatory and...