Principal Scientist

Division / Function
Early Development/Clinical Pharmacology, DMPK & Pharmacometrics/IMA

Manager's Job Title
Director Immunogenicity and Immunoanalysis

Ipsen Job Profile
Principal Scientist

Location:
Dreux Laboratories

WHAT - Summary & Purpose Of The Position
The Immunogenicity Principal Scientist is a key contributor within the Immunogenicity & Immunoanalysis team in the Clinical Pharmacology, DMPK & Pharmacometrics department. The role is responsible for leading and contributing to immunogenicity and immunoassay development activities that support Ipsen's biologics portfolio. This includes technical supervision and wet‑lab contribution, support to method development, assay transfer, and coordination of external GxP validations. The position also encompasses the drafting and review of regulatory documentation and oversight of clinical and non‑clinical studies.

A high level of scientific rigor, autonomy, and collaboration is essential. The role requires strong expertise in immunogenicity and immuno‑analytical method development, along with proven experience working with external partners (CROs) and contributing to regulatory dossiers.

This position provides the opportunity to work at the forefront of immunogenicity and immunoanalysis science, to support the development of cutting‑edge biologics, and to collaborate closely with cross‑functional teams in a dynamic and innovative environment.

WHAT - Main Responsibilities & Technical Competencies
Technical Leadership

• Provide technical guidance and scientific oversight to the Immunogenicity & Immunoanalysis laboratory team (scientist/postdoc fellow) in the development of protocols, execution of experiments, and interpretation of results for laboratory activities conducted in Dreux:

• Develop and optimize immunoassay and immunogenicity methods (ELISA, ECLA, CBA, LBA, etc.) in support to Ipsen's asset portfolio

• Explore and implement innovative technologies and platforms.

• Occasionally contributes to wet lab activities to support the team in the development of analytical methods or the implementation of innovative technologies.

Method Transfer & Validation

• Support the transfer and validation of in-house-developed methods to CROs for GxP-compliant clinical and non-clinical studies.

Documentation & Regulatory Support

• Contribute to the drafting and review of clinical study documentation, including protocols, CSR, SAP, SMP, DTP, Lab Manual, and IOP.
• Assist in the preparation of regulatory documents (IND, IB, Immunogenicity Risk Assessment).
• Support responses to regulatory authority queries.

Study Oversight

• Monitor external clinical and non-clinical studies (GcLP, GLP, non-GLP) conducted at CROs.
• Participate in the oversight of analytical methods, validation reports, and associated sample analysis results when integrating new assets

Strategic Contributions

• Participate in due diligence evaluations for new biological entities.
• Represent the function in project teams (Early Development subteam).

HOW - Behavioural Competencies Required
Competency
Competency Behavioural Markers
Explanation of Choice
References To Job Description
Cultivate Innovation

• Questions status‑quo and adopt new approaches
• Has vision, bring ideas and possibilities and turn it into actions
• Thinks outside the box, reframes problems in different lights
• Encourages/considers/integrates different perspectives/ideas

Innovation is essential when optimizing and developing immunoassays, troubleshooting complex experimental challenges, and implementing emerging analytical technologies critical for biologics programs.

Explore and implement innovative technologies and platforms.; Develop and optimize immunoassay and immunogenicity methods…; This position provides the opportunity to work at the forefront of immunogenicity and immunoanalysis science.

Manage Complexity

• Identifies contradictory information/demands/inputs to effectively solve problems
• Develops and evaluates alternative scenario and solutions
• Able to identify what truly matters and ruthlessly focus/prioritize on making decisions with real impact

The role requires navigating complex datasets, regulatory expectations, assay performance issues, and multi‑stakeholder environments (CROs, internal teams, regulators).

Monitor external clinical and non‑clinical studies…; Assist in the preparation of regulatory documents…; Responsible for method development, assay transfer, and coordination of external GxP validations.

Communicates Effectively

• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non‑verbally) and able to relate to other points of view
• Communicates transparently, "tells it how it is" while keeping the communication respectful
• Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
• Demonstrates gravitas

Clear communication is critical for drafting regulatory documentation, guiding CROs, supervising internal staff, and ensuring high‑quality study oversight.

Contribute to the drafting and review of clinical study documentation…; Support responses to regulatory authority queries.; Provide technical guidance and scientific oversight…

Collaborates

• Collaborates and communicates without boundaries, continuously removes organizational barriers
• Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset

Success requires strong cross‑functional collaboration (development teams, assay groups, CROs, regulatory, early development subteams).

Collaborate closely with cross‑functional teams…; Represent the function in project teams…; Support the transfer and validation to CROs.

Excellence in Execution

• Approaches priority setting and setting the stage through the lens of execution
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society
• Able to be focused and performance‑driven with clear KPIs
• Plans and aligns effectively (steps, resources, timelines etc.)
• Displays a commitment to best practice sharing and setting
• Promotes single point of accountabilities.

The position requires precise execution of immunogenicity studies, regulatory documentation, method validation, and oversight of CRO‑conducted work to ensure compliance and scientific rigor.

Support the transfer and validation for GxP‑compliant studies.; Participate in the oversight of analytical methods…; Provide technical guidance in protocols and experiments.

HOW - Knowledge & Experience
Knowledge & Experience :

• 5+ years in pharmaceutical/biotech industry with a focus on immunoassays and ADA detection, or at least 3 years in a CRO environment in relevant domains.
• Proven experience in developing immunoassays and cell-based assays (CBA, ECLA, ELISA, LBA) in immunoanalysis and Immunogenicity.
• Knowledge of GLP/GxP standards and experience in the management of external partners/CROs.
• Ability to contribute to the preparation of regulatory documentation.
• Understanding of DMPK requirements for regulatory submissions (IND, IB) and clinical study preparation / execution.
• Demonstrated scientific rigor, autonomy, and a strong ability to work collaboratively in a dynamic and innovative environment.

Education / Certifications

• PhD/Postdoc in Immunology or Immunogenicity or at least Master's degree (Bac +5) in Immunology or related field.

Language(s) (preferred)

• Strong proficiency in written and spoken English and French is required.