Business Process Lead in London

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 endeavour 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 company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

Job Description:

POSITION Business Process Lead

WHAT - Summary & Purpose of the Position The Business Process Lead is a senior individual accountable for the end-to-end management of Clinical Development business processes. The role will be responsible to ensure that clinical development processes consistently deliver quality, efficiency, and optimise clinical operations outcomes.

WHAT - Main Responsibilities & Technical Competencies

• Strategy & Vision
  • Define Clinical Development Process Objectives and Management: Align the process vision, goals, and mission with R&D organisational strategies.
  • Set Targets: In conjunction with other CDO/R&D leaders embed the agreed Key Performance Indicators in the CDO framework and processes.
  • Design and maintain the process Framework: Establish how the processes should be managed within the CDO organization.
  • Systems Support: Support evaluation and selection of systems to be used across the Clinical Operations functions. Ensure integration of systems and processes to drive operational efficiencies across the CDO functions.
• Governance & Compliance
  • Establish Policies: Develop and maintain the rules, procedures, and controls governing the CDO processes.
  • Ensure Adoption: Validate that team members (colleagues and/or FSP) are acting in accordance with the agreed policies and define corrective actions if they aren’t.
  • Risk Management: Identify potential roadblocks, conflicts, and risks within the process and put mitigating measures in place.
• Performance Monitoring
  • Track KPIs: Continuously monitor and report KPI scorecard to CDO Leadership and Asset Teams on process performance against target plans.
  • Evaluate Outcomes: Analyze data gathered from the process to ensure it yields the expected quality and return on investment.
• Continuous Improvement
  • Drive Process Optimisation: Champion continuous improvement to eliminate inefficiencies.
  • Define process changes that mature the Clinical Development processes and improve their overall health. Conduct external environment scanning for new ways to optimise the processes across the Clinical Development Paradigm.
  • Support training material review for new systems and processes.
• Stakeholder Alignment
  • Cross-Functional Coordination: Synchronize process goals across Clinical Development and cross functional lines that support the asset teams, to prevent disjointed, siloed work.
  • Act as the Escalation Point: Serve as the definitive decision-maker and single point of contact when major process-related issues or improvement suggestions arise.

HOW - Behavioural Competencies Required

• Excellence in Execution: Planning and prioritizing work to meet commitments aligned with organizational goals. Consistently achieving results, even under tough circumstances.
• Ensures Accountability: Holding self and others accountable to meet commitments.
• Communicates Effectively: Developing and delivering communications that convey a clear understanding of the unique needs of different audiences (CPMs and CRAs).
• Taking a stand (courage): Stepping up to address difficult issues, saying what needs to be said to optimise quality and compliance.

HOW - Knowledge & Experience

Knowledge & Experience (essential): A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least 5 years of GXP experience within clinical research. Well-developed skills and knowledge of clinical operations business processes and practices (i.e., SOPs governing clinical research activities). A minimum of 4 years experience in development, management and leadership of Clinical Operations Business Process. Demonstrated ability to deliver a culture of continuous improvement. Planning and tracking skills, able to see the big picture, well organized, focused on results, customer focused, capable of managing multiple projects, excellent time management with respect to priorities and self-management.

Knowledge & Experience (preferred): Knowledge of the overall drug development process. Experience across all Clinical Trial Phases 1-4 would be preferred. Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset. Ability to influence and motivate professional colleagues and stakeholders. Proven conflict resolution/management and negotiation skills. Ability to independently plan, organize, coordinate, manage and execute assigned tasks. Demonstrated clarity of communication. Demonstrated ability to influence key internal and external stakeholders. Experience of the key customers’ business processes and practices. Demonstrated ability to engage with authorities, trade associations and key clinical trial sites.

Education / Certifications (essential): Bachelors Degree in life sciences or a professional degree in life sciences (e.g., Nursing, Pharmacy).

Education / Certifications (preferred): Project Management Certificate (PMP/PRINCE2 etc.).

Language(s) (essential): Global role so Fluency in English is critical.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.