Clinical Biomarker Principal Scientist F/m

The 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 trials as well as initiate, implement and support cross-functional process optimization in conjunction with other biomarker-related operations.

**Primary responsibilities**:

- Defines clinical biomarker strategies and establishes biomarker plans for target engagement, pharmacodynamics, mechanism of action, and patient selection
- Anticipates need for companion diagnostic and adapts biomarker strategy accordingly
- Supports the translational team in defining the translational strategy so as to guide the clinical biomarker strategy
- 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 and preparation 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 REED 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.

**Knowledge, abilities & experience**

**Experience**:

- 10+ 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
- Experience in NGS and/or companion diagnostics
- 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