Clinical Scientist, Rare Diseases (Remote- based)

Title:

Clinical Scientist, Rare Diseases (Remote- based)

Company:

Ipsen Bioscience, Inc.

Job Description:

Primary Responsibilities:

• To provide scientific and clinical development support for products within assigned therapy area.
• Monitor subject data and communicate with site study teams to obtain updates on subject status.
• Address routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol
• Support development and execution of medical & clinical strategy for assigned product(s).
• To review trial data and work with Global Patient Safety to update regulatory documents ie investigator brochure, development safety update report.
• Development and review of clinical study documents ie ICF, protocol updates, CSR.
• Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, biostatistics, data management, and pharmacovigilance to ensure quality processes and deliverables
• Assist in the review, analysis and reporting of clinical trial data and related publications.
• Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
• To lead on preparations for Data Monitoring Committee meetings including quarterly safety updates and appropriate slide presentations.
• Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution.
•  Ensure concise written reports are provided as needed.
• Collaborates with Global Asset Lead, Clinical development Lead, Clinical Operations, Global Patient Safety, Biometry & Data Management and any other relevant function to ensure that all development and asset support activities are coordinated and consistent.
• 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.
• Provides expert scientific clinical development advice to the asset team for the development of
• Phase I-IV clinical programs.
• Reviews clinical protocols and clinical study reports for scientific and operational accuracy.
• Participates in drug safety surveillance for development projects.
• Develops and demonstrates expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
• Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders.

Knowledge, Abilities, and Experience

• MD, Pharm D, pharmacist, or PhD or nursing qualification strongly preferred. Equivalent combination of education and relevant experience may be considered on a case-by-case basis. Scientific/healthcare field experience relevant to the application. Advanced degree preferred.
• Significant experience (5+ years) of clinical research and organizational management within the pharmaceutical industry, a CRO, academia or similar organization.
• Attention to detail and prompt follow up on actions
• Demonstrated ability to collaborate in a matrix environment
• Experience in assisting and providing support for regulatory submissions such as IND/CTA/NDA/MAA and
• Experience in designing and conducting Phase I-III clinical trials, including importance of translation into CRFs and SAP
• Experience in reviewing clinical trial data and being able to quickly assimilate to a wider audience.

Key Technical Competencies Required

• Expertise and/or experience in rare diseases highly desired
• Demonstrated in-depth understanding of drug development
• Demonstrated ability to communicate and plan effectively across departments
• 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.
• Complex 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.

In order to maintain a safe work environment, Ipsen requires all employees to be fully vaccinated (with booster if eligible) against the Covid 19 virus at the time of employment.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.