Senior Scientist Clinical Biomarkers
il y a 1 semaine
**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.
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