Overview
As Clinical Program Director, you will lead global clinical development programs in oncology, steering cross-functional teams to deliver pivotal studies on time and budget. You will shape clinical development plans, manage external partnerships, and ensure study quality and regulatory readiness. You work closely with asset teams to drive efficient operations, informed by market insights and a focus on patient impact. This role offers the opportunity to influence Ipsen’s oncology portfolio and collaborate across global functions to accelerate meaningful therapies.
Responsibilities
- Lead and develop CPMs, CMLs, and CTAs; foster collaboration and accountability across the team
- Oversee clinical development plans (CDP), budgets, resourcing, and timeline forecasting for programs
- Define clinical operations strategy (CRO selection, country/site strategy, recruitment targets) and ensure alignment with asset teams
- Manage relationships with Service Providers; drive issue escalation and timely resolutions
- Provide expert input on clinical documents (protocols, CSRs, INDs, NDA/MAA updates) and support submission teams
- Represent clinical operations on Asset teams and contribute to advisory boards and scientific committees
- Drive continuous process improvements, training, and adaptation to new business models
- Ensure compliance with GCP, FDA/EMA regulations, ICH guidelines, and Ipsen SOPs
Key requirements
- 10+ years of Clinical Operations experience in Ph1-3 oncology programs
- Experience with pivotal filing studies and global regulatory submissions
- Strong understanding of drug development processes, regulatory frameworks, and clinical documentation
- Proven leadership and budget management, risk management, and vendor management
- Excellent cross-cultural communication and stakeholder management skills
- Ability to operate strategically and translate plans into operational execution
- Fluent in English
- leadership and team development
- communication and interpersonal skills
- strategic thinking
- Clinical Operations management
- Budgeting and resource forecasting
- CRO/vendor management
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