Head of Bioanalysis, Immunoanalysis and OneLab

il y a 1 jour


Dreux, Centre-Val de Loire, France Ipsen Temps plein

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 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.

Main Responsibilities
WHAT -
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 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 - Behavioural Competencies Required
Competency
Competency Behavioural Markers
Explanation of Choice
References To Job Description
Drive Vision and Strategy (2)

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.

Provides strategic, scientific, and operational leadership for Ipsen's integrated bioanalytical and immunoanalytical functions.

Accountable for the vision, direction, and performance of the Bioanalysis and Immunoanalysis/Immunogenicity groups.

Driving operational excellence, innovation, and cross-functional collaboration to accelerate the development of transformative therapies for patients.

Cultivate Innovation (7)

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

The role must foster scientific excellence and innovation, championing new technologies and best practices to enhance laboratory capabilities and scientific impact.

Champion the adoption of new technologies, digital solutions, and best practices to enhance laboratory capabilities and scientific impact.

Fostering a culture of scientific excellence, innovation, and operational efficiency.

Promote a culture of continuous improvement, knowledge sharing, and scientific innovation within the team and across the organisation.

Ensures Accountability (26)

Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects).

Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear.

Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus.

Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others.

Follows through on commitment and makes sure others do the same.

The role is responsible for regulatory-compliant data delivery, operational excellence, and ensuring all commitments are met across complex, multidisciplinary teams.

Ensuring the delivery of high-quality, regulatory-compliant data for pharmacokinetics, pharmacodynamics, and immunogenicity assessments across all phases of drug development.

Lead, mentor, and develop multidisciplinary teams, promoting talent growth, collaboration, and a high-performance culture.

Ensure full compliance with all relevant regulatory, quality, and EHS standards.

Collaborates (23)

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.

The role requires cross-functional collaboration, both internally and externally, to drive operational excellence and accelerate drug development.

Driving operational excellence, innovation, and cross-functional collaboration to accelerate the development of transformative therapies for patients.

Manage relationships with external partners (CROs, academic collaborators), including technical oversight, contract negotiation, and performance monitoring.

Represent the function in cross-functional project teams, governance bodies, and regulatory interactions, providing expert input and ensuring alignment with portfolio priorities.

Develops/Coaches Talent (15)

Able to identify and align career goals, and blend organizational objectives into a cohesive development plan for self and team.

Able to coach

Provides structured, actionable, regular and directional feedback and acts as a coach to empower people to own their own growth/development.

Prepares their own succession plans.

Displays a radically human-centered mindset; puts people first; focuses on doing good.

Demonstrates ability to build team effectiveness.

Leading, mentoring, and developing multidisciplinary teams is central to this role, ensuring talent growth and a high-performance culture.

Lead, mentor, and develop multidisciplinary teams, promoting talent growth, collaboration, and a high-performance culture.

Promote a culture of continuous improvement, knowledge sharing, and scientific innovation within the team and across the organisation.

Fostering a culture of scientific excellence, innovation, and operational efficiency.

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.

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.


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