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You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't
Lead the design and execution of clinical pharmacology strategies and corresponding studies across multiple programs. Develop innovative and meaningful clinical pharmacology approaches that accelerate and de-risk drug development Define dose selection,
Evaluate and develop product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical
Develop and lead clinical biomarker strategies across Ipsen's oncology and rare disease portfolio to support critical development and portfolio decisions. Define biomarker plans to support target engagement, pharmacodynamic and mechanistic understanding,
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity. Contribute to medical monitoring activities and support ongoing assessment of