Head of Bioanalysis, Immunoanalysis and OneLab

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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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 Ipsens 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 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 Ipsens 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 Ipsens R&D strategy.

Provides strategic scientific and operational leadership for Ipsens 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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