Clinical Program Oncology Director

Company: Ipsen Biopharm Ltd

About 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.S., France, and 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. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence, and impact. At Ipsen, every individual is empowered to be their true selves, grow, and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

WHAT - Summary & Purpose of 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 programs or multiple indications in a program.

WHAT - Main Responsibilities & Technical Competencies

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 organization:
• 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, continuous 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 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 are followed and appropriately shared and aligned at AT level, and with his/her 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 Analyzing 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.
• Analyzes and recommends solutions to his/her line manager and other Heads of Department within CDO and R&D on the organization 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.