Director, Clinical Development Programs

at  Ipsen Biopharm Ltd

KNOWLEDGE, ABILITIES & EXPERIENCE

Qualifications and experience required:

• Life sciences degree and experience in Pharma, Biotech or CRO organizations12+ years of Clinical Operations experience and specific experience in managing Ph1-3 global aesthetic medicine clinical studies/programs. Experience in managing pivotal filing studies and global submissions
• Experience in line and team management. Experience in building high performing teams through talent development and coaching, developing honest relationships, and generating trust by demonstrating consistency between words and actions
• 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 tools
• Experience in outlining Clinical operations strategy and ensuring effective delivery Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority
• Experience of working with multidisciplinary groups and ability to work within a team environment.
• Experience of managing and developing relationships with Service Providers (SPs).
• Proficient in risk management to prevent and overcome complex safety and compliance related issues during clinical program implementation
• A good understanding of the drug development process. 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. Experience in starting Ph1-3 studies, NDA, MAA activities
• Experience of preparing and managing clinical study budgets
• Excellent organisational and management skills
• Excellent verbal and written communication skills

SUMMARY / PURPOSE OF THE POSITION

• The Clinical Program Director holds full accountability for the global aesthetics clinical development program(s) in scope, leading and developing a team of Clinical Project Managers, Clinical Monitoring Leads and CTAs
• He/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 manner
• 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, ensuring cross-functional oversight of all program and study related activities
• The CPD leverages market/industry insights to drive innovation and shape the company processes and programs to increase efficiency and collaboration
• CPD could manage 1-2 program or multiple indications in a program

TEAM MANAGEMENT RESPONSIBILITIES:

Accountable for forecasting/managing resources and for driving one-team, transparency, accountability and collaboration behaviors within his/her team and transversally within the organisation:

• 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 for aesthetics, in collaboration with his/her line manager,
• Fosters a culture of collaboration, accountability, continues improvement, and operational excellence

CLINICAL PROGRAM MANAGEMENT RESPONSIBILITIES

• Provides clinical and operational expertise and guidance for the design, implementation strategy, resourcing and budgetary planning for clinical programs. Works closely with the Therapeutic area Medics, Biostats and cross-functional team members on the programs to outline the design of the Clinical Development Plan (CDP); Target product profiles (TPP) etc
• Accountable for forecasting CDO resources (internal/external), timelines and budgets needed on the clinical programs to deliver on the milestones. Sits on the Clinical Development teams and represents clinical operations on the Asset team
• Accountable 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 etc
• Ensures 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 and accountable for managing relationships with Service Providers (SP). Responsible for issue escalation, timely resolution of issues and supporting the CPMs in the SP oversight and the delivery on the clinical studies
• Responsible and accountable for ensuring all the clinical studies within the program are delivering on time and within budget
• Provides 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…), and to ensure that the assigned dedicated CPMs are providing an expert/functional review of study documents (e.g. Protocol, Reporting and Analysing Plan, Clinical Study Reports and other key documents) during the course of the clinical program
• Contributes as required to advisory boards, expert scientific committees, and on submission teams
• Brings in the industry insights into Ipsen to ensure we are building the organization to the future state
• Analyse 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.
• Drives changes in processes for continuous improvement, trainings and adaptation to business model changes.
• Ensures all program activities within the framework are in compliance with Global SOPs, and other documentation in force within the Ipsen Group, ensuring timely reading and understanding of relevant SOPs.
• Performs any other activity as may reasonably be required by his/her line manager from time to time