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Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the
Leads the development and delivery of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
You will oversee a team responsible for managing the end-to-end regulatory artwork process for pharmaceutical and non-pharmaceutical products across Europe. In addition to your leadership responsibilities, you’ll remain actively involved in daily
Lead the clinical development organization within the immunology TA (over 50 physicians and scientists), supporting, mentoring and coaching the clinical development teams across indications and assets. Ensure appropriate resourcing of the clinical teams