Title: Business Process LeadCompany: 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.K, we tackle areas of high unmet medical need through research and innovation. For more information, visit us at and follow our latest news on LinkedInand Instagram. POSITIONBusiness Process LeadWHAT - Summary & Purpose of the PositionThe 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 optimize clinical operations outcomes. In conjunction with other CDO/R&D leaders embed the agreed Key Performance Indicators in the CDO framework and processesDesign and maintain the process Governance & ComplianceEstablish Policies: Develop and maintain the rules, procedures, and controls governing the CDO processes. 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 MonitoringTrack 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.Conduct external environment scanning for new ways to optimise the processes across the Clinical Development ParadigmSupport training material review for new systems and processes5. Stakeholder AlignmentCross-Functional Coordination: Synchronize process goals across Clinical Development and cross functional lines that support the asset teams, to prevent disjointed, siloed work. Able to be focused and performance-driven with clear KPIs. Taking a stand (courage)Stepping up to address difficult issues, saying what needs to be said to optimise quality and complianceconsistently speaks up and challenges the status-quo; Quality driven; Faces fears, demonstrates appetite for stepping out of their comfort zone when challenging quality and complianceHOW - Knowledge & ExperienceKnowledge & 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 ProcessDemonstrated ability to deliver a culture of continuous improvementPlanning 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 of the overall drug development processExperience across all Clinical Trial Phases 1-4 would be preferredExperience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an assetAbility to influence and motivate professional colleagues and stakeholdersProven conflict resolution/management and negotiation skillsAbility to independently plan, organize, coordinate, manage and execute assigned tasksDemonstrated clarity of communicationDemonstrated ability to influence key internal and external stakeholders Experience of the key customers' business processes and practicesDemonstrated ability to engage with authorities, trade associations and key clinical trial sitesEducation / Certifications (essential): Bachelors Degree in life sciences or a professional degree in life sciences (eg Nursing , Pharmacy)Education / Certifications (preferred): Project Management Certificate (PMP/PRINCE2 etc.)Language(s) (essential):Global role so Fluency in English is critical#LI-MM1 #LI-hybridWe are committed to creating a workplace where everyone feels heard, valued, and supported; The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. 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. Cambridge One MainType: Full time
Project Implementation and Training Team Leader in London employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer that prioritises a human-centric workplace culture, fostering collaboration and excellence. With a commitment to employee growth, Ipsen offers opportunities for continuous improvement and innovation in the biopharmaceutical field, particularly in vibrant locations like Paris and London. Employees are empowered to thrive, making a meaningful impact on patients and society while enjoying a supportive environment that values diverse perspectives.
