Head of Bioanalysis, Immunoanalysis and OneLab

Ipsen Pharma

Dreux, France

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 Immunoanalysis/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 the development of transformative therapies for patients.

WHAT - Main Responsibilities & Technical Competencies

Main Responsibilities:

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 programs;
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 the 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 - Knowledge & Experience

Knowledge & Experience (essential):

Extensive Industry Expertise: 10+ years in pharmaceutical/biotech within preclinical and clinical development, with a proven record of 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: Strong understanding of clinical trial management, data management, and the end-to-end drug development process;
Operational Excellence: Skilled in project management, including planning, prioritization, problem-solving, and organization; adept at handling multiple priorities;
Influential Interpersonal Skills: Proven ability to build strong relationships and influence stakeholders across diverse functions and cultures;
Attention to Detail & Communication: Exceptional accuracy, clear and direct communication, and cultural sensitivity;
Leadership & Management: Strong managerial capability with a recognized leadership profile;
Strategic Vision: Ability to maintain a big-picture perspective while managing critical details;
Professional Representation: Consistently represents the organization with professionalism and integrity;
Proactive & Positive: Self-directed, flexible, and solution-oriented with a positive attitude;
Commitment to Growth: Passionate about continuous learning and developing self and others.