Title:Clinical Program Oncology DirectorCompany:Ipsen Biopharm LtdAbout 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.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. For more information, visit us at and follow our latest news on LinkedInand Instagram.Job Description:WHAT - Summary & Purpose of the PositionThe Clinical Program Director (CPD) holds full accountability for the global clinical development program(s) in scope, leading and developing a team of Clinical Project Managers (CPMs), Clinical Monitoring Leads (CMLs) and CTAsHe/she drives excellence in external stakeholder management and leads the clinical partnerships for the programs and studies in scope, ensuring that Ipsen is seen as a partner of choice for external stakeholders and that any issues are addressed in a timely mannerThe CPD is responsible for the clinical development plan and leads all clinical development operations aspects for the assets in scope at Asset Team level, ensuring cross-functional oversight of all program and study related activitiesThe CPD leverages market/industry insights to drive innovation and shape the company processes and programs to increase efficiency and collaborationCPD could manage 1-2 program or multiple indications in a programWHAT - Main Responsibilities & Technical CompetenciesTeam Management responsibilities:Recruits, manages, develops, mentors and trains Clinical Project Managers (CPMs), Clinical Monitoring Leads (CMLs) and Clinical Trial Assistants (CTAs) as applicable, within area of responsibility,Fosters a culture of collaboration, accountability, continues improvement, and operational excellenceClinical Program Management responsibilitiesProvides clinical and operational expertise and guidance for the design, implementation strategy, resourcing and budgetary planning for clinical programs. Works closely with the Therapeutic area Clinical Development Managers, Biostats and cross-functional team members on the programs to outline the design of the Clinical Development Plan (CDP); Sits on the Clinical Development teams and represents clinical operations on the Asset teamAccountable and responsible for outlining the clinical operations strategy to deliver on the clinical development plans. This includes CRO selection, country/site selection strategy, recruitment rates etcEnsures that the timelines and all key deliverables for the clinical study clinical are followed and appropriately shared and aligned at AT level, and with her/his line manager, TA CDO Head and Head of CDO in order to support the delivery of clinical development objectives and achieve Clinical Excellence.Responsible for issue escalation, timely resolution of issues and supporting the CPMs in the SP oversight and the delivery on the clinical studiesResponsible and accountable for ensuring all the clinical studies within the program are delivering on time and within budgetProvides expertise as required as a contributing author in the development of clinical documents (e.g. study concept, annual updates of the Investigator Brochures, IND, Briefing documents etc…), Protocol, Reporting and Analysing Plan, Clinical Study Reports and other key documents) during the course of the clinical programContributes as required to advisory boards, expert scientific committees, and on submission teamsBrings in the industry insights into Ipsen to ensure we are building the organization to the future stateAnalyse and recommend solutions to his/her line manager and other Heads of Department within CDO and R&D on the organisation and participation in effective clinical trial programs.Strategic vision is essential to guide teams and align with long-term goals.§ The CPD is responsible for the clinical development plan and leads all clinical development operations aspects for the assets in scope at Asset Team level.§ Ensures Accountability (26)• Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects);• The Clinical Program Director holds full accountability for the global clinical development program(s) in scope.§ Leads all clinical development operations aspects for the assets in scope.HOW - Knowledge & ExperienceKnowledge & Experience (essential):10+ years of Clinical Operations experience in Pharma, Biotech or CRO organization in managing Ph1-3 global clinical studies/programs in Oncology Therapeutic Area.Experience in preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and toolsExperience in outlining Clinical operations strategy and ensuring effective delivery. Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementationExperience of preparing and managing clinical study budgetsExcellent organisational and management skillsStrong leadership and line management capability and experienceIs an effective Team leader, experienced in building high performing teams through talent development and coaching, developing honest relationships, and generating trust by demonstrating consistency between words and actionsExcellent communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity / interact at all levels within the business and with external partners. Flexible; Excellent IT and Microsoft Office skillsKnowledge & Experience (preferred): Experience in First-in-human studies in oncology strongly preferred.Education / Certifications (essential): Bachelor’s degree in a relevant life sciences discipline is required.Education / Certifications (preferred): Advanced degree (Master or PhD level) or equivalent advanced qualification(s) is preferredLanguage(s) (essential): Fluent in English.#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
Clinical Program Manager 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.
