Clinical Programm Director Oncology F/m

il y a 2 semaines

BoulogneBillancourt, France Ipsen Innovation (SAS) Temps plein

**Summary / purpose of the position**
- To provide clinical and operational expertise and guidance for the design, implementation, resourcing and budgetary planning for clinical programs managed through Asset Teams and/or Global Project Team (GPT)
- To work in conjunction with the TA Medical and/or REED Expert as applicable, and the Asset Operational Leader(s) (AOLs) and other AT/GPT members in the creation and seamless execution of deliverables (e.g. Target Product Profiles, Asset/Project Team Objectives, Integrated Development Plans or Submission dossiers, forecast and budget).
- To be the key contact point and representative for all CDO related activities at AT/GPT level
- To lead the clinical development program(s) (planning, implementation, monitoring/controlling, budget, quality, communication, risk assessment, stakeholder management, procurement etc..) ensuring the full integration of studies management within the Global Project Management plans
- To ensure cross functional oversight of all study related activities (TAPV/CMC/GRA )
- To ensure selection and global SP oversight through the supervision of Ipsen CPM
- To provide expert clinical support to Business Development as required during Due Diligence activities and ensure that Head of Clinical Programs concurs with the assessment and recommendations
- To support the Head of Clinical Programs for the planning, resourcing and management of clinical research personnel under program area of responsibility.
- To recruit, manage, mentor, train, review, develop and appraise all Clinical Project Managers (CPMs), Clinical Leads (CLs) and Clinical Trial Assistants (CTAs) as applicable, within area of responsibility, in collaboration with the Head of Clinical Programs.
- To analyse and recommend solutions to the Head of Clinical Programs and other Heads of Department within CDO and R&D on the organisation and participation in effective clinical trial programs.
- To drive changes in processes for continuous improvement and adaptation to business model changes.

**Main responsibilities / job expectations**
- To take overall line management responsibility for development, support, review, training and appraisal of all direct reports
- To coordinate and manage from a program project centric perspective all internal and external project management resources involved in the clinical programs
- To ensure that the timelines and all key requirements for clinical project plans are followed and appropriately shared with the Head of Clinical Programs to ensure alignment at AT/ GPT level, in order to support the delivery of clinical development objectives and achieve Clinical Excellence.
- To coordinate, an initial budget proposal and updates with the support of the project financial controller and with all necessary HoF inputs, track, reconcile and manage the budgets associated with these Clinical programs, and secure approvals by the Head of Clinical Programs, Head of CDO, andAOLs as required for the project success. To ensure that this information is timely and accurately forwarded to the Budget and Resources Team
- To take overall accountability for clinical studies within a Program in respect of: ensuring a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals through validation of key activities (study budget preparation, study timelines, country/site selection etc )
- To ensure that cross-functional total headcount involved in CDO in a clinical study allows an appropriate conduct and delivery on time and quality of deliverables
- To provide 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 provide with the assigned dedicated CPM, 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
- To advise and participate in the SP selection in collaboration with the Procurement department and CTE function, providing support to Ipsen CPM for SP oversight and ensuring consistency within and across programs.
- To participate and contribute along with Procurement department to SP oversight meetings
- To attend and contribute as required to advisory boards, expert scientific committees.
- To contribute as clinical expert in the submission team as applicable.
- To lead in fostering and developing a team approach to all activities associated with the implementation of clinical studies.
- To complete all of the above activities within the framework and in compliance with Global SOPs, and other documentation in force within the Ipsen Group, ensuring timely reading and understanding of relevant SOPs.
- To perform any other activity as may reasonably be required by Head of Clinical Programs from time to time

Leadership / Management
- Responsible for the talent development, provides

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