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Clinical Scientist
Il y a 4 mois
**Title**:
Clinical Scientist
**Company**:
Ipsen Innovation (SAS)
**Summary / purpose of the position**
- Providing leadership and management within Clinical Development (CD) 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 product(s).
- Conduct scientific literature research in support of existing or new indications for the assigned products and analyze the competitor environment
- Ensure concise written reports are provided as needed.
- Support Medical Monitor and Medical Development Director to provide scientific leadership in planning, conducting and executing clinical trials including review of clinical study documents, reports, data review and interpretation of the trials generated data for future use in next studies/programs.
- Provide relevant clinical scientist expertise to internal asset sub-teams, including clinical operations, medical writing, biostatistics, data management, regulatory, medical affairs and pharmacovigilance to ensure quality processes and deliverables.
- Contribute to preparation and execution of clinical trials as part of the specific Study Team(s)
- Assist in the review, analysis and reporting of clinical trial data.
- Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
- Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution.
**Main responsibilities / job expectations**
- Leads and/or participates in marketing and clinical/medical advisory panels, data monitoring/steering committees and investigator meetings.
- Remains up to date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities, indication specifics and geographic areas particularities.
- Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs.
- Contribute to development of clinical studies and reviews clinical protocols, related documents, and clinical study reports for scientific and operational accuracy.
- Leads execution of clinical studies from the medical development perspective
- Participates in drug safety surveillance for Development projects.
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
- Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.
**Knowledge, abilities & experience**
- Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
- 5+ years experience of clinical research and organizational management within the pharmaceutical industry, a CRO, or similar organization.
- Demonstrated ability to collaborate in a matrixed environment.
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
- Experience in designing and conducting Phase I-III clinical trials; and/or significant late-stage development research.
**Key Technical Competencies Required**
- Expertise in neurological diseases and/or experience in rare diseases highly desired.
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within therapy area.
- Working knowledge of regulations relating to drug development and promotional activities
- Demonstrated ability to communicate and plan effectively with other Ipsen departments and to respond to inquiries or complaints from customers.
- Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences.
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Ipsen; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results.
**Complexity and Problem Solving**:
- Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results.
- Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts.
- Requires high degree of problem-solving ability, understanding of objectives and processes across multiple organizational functions.
**Internal and External Contacts**:
- Position is accountable to the Medical Development Director
- Dotted line reporting to Asset Team Leader for the assigned assets
- Cross-functional asset sub-teams teams for assigned assets
- Key academic, regulatory, professional leaders.
**Other Requirements**:
- Availability to trave
