Senior Scientist Clinical Biomarkers
Il y a 4 mois
**Primary responsibilities**:
- Contributes to the development of clinical biomarker strategies and establishes biomarker plans for target engagement, pharmacodynamics, mechanism of action, and patient selection that are suitable for informed decision-making
- Monitors clinical implementation and validation of biomarkers
- Selects the most relevant technical strategy to fulfill biomarker objective: FACS, tissue imaging, genomics, proteomics
- Implements biomarker plans for clinical trials into clinical study documentation (Protocols, SoA, lab manual)
- Actively participates in meetings and effectively interfaces with technical/scientific experts in all functions to obtain appropriate resources to deliver on biomarker goals
- Works closely with clinical operation teams and CROs, to monitor ongoing biomarker activities, ensure appropriate collection and analysis of biomarker samples, coordinate data collection, data analysis, interpretation of the results.
- Identifies, selects and validates CROs for biomarker validation and analysis to ensure compliance and high quality data
- Collaborates with clinical development team to define biomarker components of statistical analysis plans
- Manages outsourcing process according to Ipsen SOPs (budget, contracts )
- Communicates effectively and impactfully across the organization within Early Development and with Clinical Development, Project Management, Regulatory, R&D and BD.
- Ensures compliance with appropriate SOP's
- Interfaces with regulatory authorities, as appropriate, in support of development objectives
- Maintains knowledge of national and international guidelines including industry standards for Good Laboratory/Clinical Practice
**EHS responsibilities**:
- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training
**Education / Certifications**:
- Minimum requirements/Education (minimum/desirable):
- PhD + Post doc in life science, preferably in oncology or immuno-oncology; ability to travel up to 5%
- An equivalent combination of relevant education and applicable job experience may be considered.
**Experience**:
- 5+ years experience in drug development in the pharmaceutical industry or in biotech, including 2+ years experience in early phase clinical biomarker
**Languages**:
- English: Business level, oral and written
- French: Business level, oral and written
**Key Technical Competencies Required**
- Eager and interested in learning and growing
- Deep understanding of the role of translational science and clinical biomarkers in drug development
- Comfortable working in a fast-paced environment
- Comfortable working in or leading a matrix team
- Ability to recognize, articulate, and accept calculated risks to make informed decisions
- Working knowledge of all functional areas of drug development, including pharmacology, toxicology, clinical development, clinical operation, quality assurance, diagnostic development
- Demonstrated scientific acumen and mechanistic understanding of disease biology
- Good analytical and problem-solving skills
- Excellent scientific written, interpersonal communication
- Strong familiarity with good clinical/laboratory practices
- Good experience working with CROs.
**#LI-Hybrid**
LI-MC1
-
Scientist Clinical Biomarkers
Il y a 7 mois
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...
-
Clinical Biomarker Principal Scientist F/m
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinThe clinical Biomarkers principal scientist will be responsible for defining the biomarker strategy, from biomarker identification, through clinical implementation, and up to companion diagnostics development, for multiple programs covering all three therapeutic areas, where needed. He/She will also be responsible for monitoring biomarkers in clinical...
-
Clinical Scientist
Il y a 3 mois
Les Ulis, France Ipsen Bioscience, Inc. Temps plein**Responsibilities**: - Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards) - Partner with the study lead on oversight of clinical trial activities, including safety reviews...
-
Clinical Scientist
Il y a 6 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** Providing leadership and management within Neuroscience Therapeutic Area Clinical Development to provide scientific and clinical development support for products (assets) within assigned therapy area. Support development and execution of medical & clinical strategy for assigned Ipsen assets(s). Conduct scientific...
-
Senior Clinical Data Manager
il y a 1 semaine
Les Ulis, Île-de-France Ipsen Pharma Temps pleinJob OverviewWe are seeking a skilled Clinical Data Manager to join our Ipsen Pharma team. As a key member of our clinical data management team, you will play a critical role in ensuring the high-quality collection, processing, and reporting of clinical data.About the RoleThe successful candidate will have a minimum of 2 years' experience as a Clinical Data...
-
Clinical Data Manager
Il y a 6 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Clinical Data Scientist set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program. He/she is accountable (quality, budget and timelines) for the Data Management...
-
Senior Clinical Monitoring Lead
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinThe Senior Clinical Monitoring lead is fully accountable for all 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 GCP guidelines and regulations. - He/she builds strong relationships with investigators and proactively acts as...
-
Clinical Data Manager
Il y a 2 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** The Clinical Data Manager set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program. He/she is accountable (quality, budget and timelines) for the Data Management...
-
Clinical Data Manager H/F
il y a 2 semaines
Les Ulis, Essonne, France Ipsen Pharma Temps pleinTitle: Clinical Data Manager H/F Company: Ipsen Innovation (SAS) Job Description: Summary / purpose of the position The Clinical Data Manager set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program....
-
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...
-
Clinical Data Manager H/F
il y a 2 semaines
Les Ulis, Essonne, France Ipsen Pharma Temps pleinTitle: Clinical Data Manager H/F Company: Ipsen Innovation (SAS) Job Description: Summary / purpose of the position The Clinical Data Manager set-up and oversees the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist in charge of the development program. ...
-
Senior Manager Training
il y a 5 jours
Les Ulis, France Ipsen Pharma (SAS) Temps plein**Purpose of the Position** Sr. Manager of Training will be responsible for developing and administering Job level training for each role within Clinical Operations. They are also responsible for developing and administering Therapeutic area training for the studies **Main Responsibilities & Technical Competencies** - Developing and executing training...
-
Non-clinical Drug Safety Senior Project Manager
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**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...
-
Senior Manager Biostatistics
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** - The Senior Biostatistician for Health Technology Assessments (HTA) is an Ipsen Global Biometry biostatistician supporting the development of HTA, in collaboration with Ipsen Health Economics and Outcomes Research (HEOR) and Global Value and Access teams. - He/She is responsible for the discussion and implementation of...
-
Senior Manager, Cmc Technical Writing
Il y a 3 mois
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob Title**:Senior Manager, CMC Technical writing Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Director/ Sr Director, CMC Regulatory Location: Balard/ Dublin/ Paddington **Summary / purpose of the position** The Senior manager, CMC-technical writing will have responsibility for the CMC (Chemistry Manufacturing and...
-
Stage - Etude Clinique
il y a 1 semaine
Les Ulis, France LFB Temps pleinQUELLES MISSIONS VOUS SERONT CONFIEES ? - Au sein du Département Développement Clinique et affaires Médicales (DCAM), vous participerez au développement et à la mise en œuvre d’études cliniques non-interventionnelles en développant des compétences sur les missions suivantes: - Participer au planning et à l’exécution opérationnelle d’études...
-
Senior Site Manager
Il y a 7 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps pleinVous voulez contribuer à un projet de grande envergure et avoir un impact sur le monde qui vous entoure ? Intégrer Janssen, la division pharmaceutique du Groupe Johnson & Johnson, leader mondial dans le domaine de la santé (126500 collaborateurs dans le monde, 265 entreprises présentes dans 60 pays), c'est participer au développement de solutions...
-
Senior Manager, Global Labelling
Il y a 4 mois
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...
-
Senior Director Regulatory Cmc Strategy
il y a 2 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders. - Takes accountability/decision making for all Global CMC-Regulatory files in the biologic cluster. - Accountable for early communication and validation from worldwide health authorities for any...
-
Clinical Team Leader
Il y a 6 mois
Issy-les-Moulineaux, France Johnson & Johnson Temps plein**Nous recherchons actuellement un.e Clinical Team Leader - Biosense Webster H/F en CDI** **Le poste est à pourvoir dès que possible et est basé soit à Reims, soit à Nancy.** **Les départements concernés sont 51, 10, 54, 57, **des déplacements Region Nord Est et France entière sont à prévoir.** Vous voulez contribuer à un projet de grande...
