Title:
Clinical Program Director Early Development Oncology
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) Early Development Oncology holds full accountability for the global operational delivery of early development oncology program(s), 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
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 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
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 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…