Clinical Program Oncology Director

Ipsen•Paris, TX

36d

About The Position

The 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 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

Requirements

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 managing pivotal filing studies and global submissions
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.
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. Organisational strategic awareness and proven ability of developing strategic solutions. Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority with strong diagnostic, analytical and process improvement skills
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
Experience of preparing and managing clinical study budgets
Excellent organisational and management skills
Strong leadership and line management capability and experience
Is 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 actions
Excellent communication skills, strong interpersonal skills, and cross-cultural understanding and sensitivity / interact at all levels within the business and with external partners. Ability to represent the company in a highly professional manner.
Experience of working with multidisciplinary groups and ability to work within a team environment.
Ability to see the big picture, while keeping an eye on the detail.
Ability to take initiative with a positive attitude in all circumstances.
Flexible; independent problem solving and self-direction.
Excellent IT and Microsoft Office skills
Bachelor's degree in a relevant life sciences discipline is required.
Fluent in English.

Nice To Haves

Experience in First-in-human studies in oncology strongly preferred.
Advanced degree (Master or PhD level) or equivalent advanced qualification(s) is preferred

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,
Fosters a culture of collaboration, accountability, continues improvement, and operational excellence
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 Clinical Development Managers, 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