Head of Bioanalysis, Immunoanalysis and OneLab

Job Title

Head of Bioanalysis, Immunoanalysis and OneLab

Division / Function

Ealy Development/Clinical Pharmacology, DMPK and Pharmacometrics

Location

Dreux

WHAT - Summary & Purpose Of The Position

The Head of Bioanalysis, Immunoanalysis and OneLab provides strategic, scientific, and operational leadership for Ipsen’s integrated bioanalytical and immunoanalytical functions, supporting the entire R&D portfolio. This role is accountable for the vision, direction, and performance of the Bioanalysis and Immunogenicity groups, ensuring the delivery of high‑quality, regulatory‑compliant data for pharmacokinetics, pharmacodynamics, and immunogenicity assessments across all phases of drug development. In addition, the position oversees the management and evolution of the Dreux “OneLab” laboratories, driving operational excellence, innovation, and cross‑functional collaboration to accelerate development of transformative therapies for patients.

Main Responsibilities & Technical Competencies

• Provide strategic and operational leadership for the Bioanalysis and Immunoanalysis/Immunogenicity groups, ensuring alignment with Ipsen’s R&D and business objectives.
• Oversee the management, development, and continuous improvement of the Dreux “OneLab” laboratories, fostering a culture of scientific excellence, innovation, and operational efficiency.
• Direct and oversee the development, validation, and implementation of robust bioanalytical and immunoanalytical methods (e.g., LC‑MS/MS, immunoassays, cell‑based assays) to support non‑clinical and clinical programmes.
• Ensure the delivery of high‑quality, timely, and regulatory‑compliant data for pharmacokinetic, pharmacodynamic and immunogenicity assessments across all phases of drug development.
• Lead, mentor, and develop multidisciplinary teams, promoting talent growth, collaboration, and a high‑performance culture.
• Manage relationships with external partners (CROs, academic collaborators), including technical oversight, contract negotiation, and performance monitoring.
• Evaluate and mitigate immunogenicity risks, ensuring appropriate study design, execution, and interpretation in line with regulatory expectations.
• Represent the function in cross‑functional project teams, governance bodies, and regulatory interactions, providing expert input and ensuring alignment with portfolio priorities.
• Champion the adoption of new technologies, digital solutions, and best practices to enhance laboratory capabilities and scientific impact.
• Ensure full compliance with all relevant regulatory, quality, and EHS standards by championing EHS regulations, fostering a proactive safety culture, and actively contributing to regulatory submissions and continuous improvement of the EHS management system.
• Lead and engage the team in workplace safety by conducting Managerial Safety Visits, promoting accident prevention, and guaranteeing completion of all mandatory EHS training and certifications for all team members.
• Promote a culture of continuous improvement, knowledge sharing, and scientific innovation within the team and across the organisation.

Technical Competencies

• Deep expertise in bioanalytical, immunogenicity, and immunoanalytical method development, validation, and application in pharmaceutical R&D.
• Strong understanding of regulatory requirements (GLP, GCP, GxP) and quality systems.
• Proven ability to manage laboratory operations, multidisciplinary teams, and complex projects.
• Proficiency in managing external partnerships and CRO oversight.
• Excellent communication skills, with the ability to present complex scientific data to diverse audiences.
• Strong problem‑solving, decision‑making, and project‑management skills.
• Commitment to continuous learning, innovation, and the adoption of new technologies.

HOW - Behavioural Competencies Required

Drive Vision and Strategy: Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action. This role requires setting a clear vision for integrated bioanalytical and immunoanalytical functions, motivating teams, and aligning with Ipsen’s R&D strategy.

Cultivate Innovation: Questions status‑quo and adopts new approaches; brings ideas and possibilities to action; thinks outside the box; reframes problems; encourages integration of different perspectives; and enhances scientific excellence and innovation.

Ensures Accountability: Builds an environment where people have the skills and habits to ask for clarification; consults stakeholder views; coaches for decision‑consent; takes personal accountability for decisions and actions; follows through on commitments; and ensures regulatory‑compliant data delivery.

Collaborates and Communicates: Communicates without boundaries, removes organisational barriers, and focuses on continuous improvement to achieve operational excellence and accelerate drug development.

Develops/Coaches Talent: Identifies and aligns career goals, provides structured feedback, prepares succession plans, and fosters a human‑centred mindset that prioritises people and learning.

HOW - Knowledge & Experience (Essential)

• 10+ years in pharmaceutical/biotech within preclinical and clinical development, with proven leadership in cross‑functional environments.
• In‑depth knowledge of bioanalytical, immunogenicity, and immunoanalytical method development, validation, and application in pharmaceutical R&D.
• Experience managing laboratory operations and multidisciplinary teams.
• Strong understanding of regulatory requirements (GLP, GCP, BPx) and quality systems.
• Proven ability to manage external partners (CROs) and complex projects.
• Comprehensive process knowledge: clinical trial management, data management, and end‑to‑end drug development.
• Operational excellence: project‑management skills including planning, prioritisation, problem‑solving, and organisation.
• Influential interpersonal skills: building strong relationships and influencing stakeholders across diverse functions and cultures.
• Attention to detail and communication: accuracy, clear communication, and cultural sensitivity.
• Leadership & Management: strong managerial capability with recognised leadership profile.
• Strategic vision: maintaining a big‑picture perspective while managing critical details.
• Professional representation: consistently representing the organisation with professionalism and integrity.
• Proactive & positive: self‑directed, flexible, solution‑oriented with a positive attitude.
• Commitment to growth: passionate about continuous learning and developing self and others.

Education / Certifications (Essential)

• PhD or equivalent in analytical science, immunology, DMPK or related field.

Language(s) (Essential)

• English: Excellent written, verbal, and interpersonal communication skills.