Clinical Program Oncology Director in London

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 endeavour 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!

Job Description 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.

Main Responsibilities & Technical Competencies:

• Accountable for forecasting/managing resources and for driving one-team, transparency, accountability and collaboration behaviours 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, continuous 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.
• Ensures that the timelines and all key deliverables for the clinical study 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.
• 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.

Behavioural Competencies:

• Drive Vision and Strategy: Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action.
• Ensures Accountability: Ensures single accountable referents per task/project/outcome; Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear; Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others.

Knowledge & Experience (essential):

• 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).
• Thorough knowledge of FDA and EMA regulations, ICH guidelines, GCP and key Clinical Operations principles.
• Experience in outlining Clinical operations strategy and ensuring effective delivery.
• Excellent organisational and management skills.
• Strong leadership and line management capability and experience.
• Excellent communication skills, strong interpersonal skills, and cross‑cultural understanding.

Education / Certifications (essential):

• Bachelor’s degree in a relevant life sciences discipline is required.

Language(s) (essential):

• Fluent in English.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.