Galderma SA
Global Head of Dermatological Skincare(m/w/x)
Vollzeitnur vor OrtSenior
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GAGalderma SA
Head of Medical Experts, Therapeutic Dermatology(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Lead medical input for global dermatology clinical development programs. Medical Degree and 10+ years drug development experience required. Global team leadership, resource planning, and ICH/GCP knowledge essential.
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Anforderungen
- Medical Degree
- Dermatologist with experience in Therapeutic Dermatology and clinical development knowledge
- Minimum 10 years drug development experience in Therapeutic Dermatology
- Minimum 5 years demonstrated leadership, management, and accomplishment conducting clinical trials in Therapeutic Dermatology
- Excellent knowledge of ICH/GCP guidelines, basic GMP/GDP knowledge
- Experience with regulatory submissions and health authority interactions
- Proven ability to interpret and present efficacy and safety data from clinical trials in Therapeutic Dermatology
- Demonstrated technical knowledge of study designs in Therapeutic Dermatology
- Experience working with and managing CROs and consultant Medical Experts in Therapeutic Dermatology
- Excellent interpersonal and communication skills, high learning agility
- Fluent oral and written English
- Willingness to travel for meetings nationally and internationally (estimated 20%)
Aufgaben
- Provide lead medical input and expertise for Therapeutic Dermatology clinical development programs
- Ensure clinical development aligns with Galderma quality management system, international standards, and regulatory requirements
- Lead a global team of internal and external Medical Experts
- Plan and allocate resources for the group's activities
- Organize activities in collaboration with other functional leaders
- Prepare and present regular updates to senior management and stakeholders
- Develop and improve SOPs and working instructions for Clinical Sciences
- Contribute to building high-performing teams across Galderma R&D
- Design and implement Clinical Development Plans for Therapeutic Dermatology
- Provide clinical and medical strategy for development plans and documents
- Interact with external and internal stakeholders on medical and scientific matters
- Advise on medically relevant questions during study execution
- Develop presentation materials for advisory boards and clinical events
- Review and interpret clinical trial safety data
- Provide medical input for development of TPPs and study documents
- Support medical and scientific aspects of data review and study documents
- Evaluate Therapeutic Dermatology product benefit-risk profile
- Defend medical positions at regulatory authority meetings
- Prepare and review clinical CTD submission modules
- Address medical Q&A from protocol design to study implementation and results submission
- Plan and execute publication and clinical communication strategy
- Perform other duties as assigned
Berufserfahrung
10 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Englisch – fließend
Tools & Technologien
ICH/GCPGMP/GDP
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Das Unternehmen ist ein führendes Dermatologieunternehmen, das injizierbare Ästhetik, dermatologische Hautpflege und therapeutische Dermatologieprodukte anbietet.
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