Serves as group lead (GL) for the company-sponsored clinical trials and development programs in the therapeutic area of functional gastrointestinal and gastrointestinal motility disorders. Responsible for guiding the clinical development strategy and ensuring the scientific integrity of clinical trials within this therapeutic area. GL collaborates with Clinical Research teams from other therapeutic areas and serves as a key liaison between Clinical Research Gastroenterology II, Global Safety, Pre- and Early Clinical Research, and Regulatory and Medical Affairs. GL drives execution for assigned projects in collaboration with other cross-functional stakeholders.
Key Responsibilities
- Line manager for the organization/project management of clinical studies in the Gastro II department
- Transfer of project responsibilities to assigned employees
- Review and approval of critical development documents (e.g., Clinical Trial Protocol, master ICF, Statistical Analysis Plan, Clinical Trial Protocol)
- Review and negotiation of study budgets with service providers (e.g., CRO, central laboratory)
- Review and approval of investigator and vendor contracts (e.g., CRO, central laboratory)
- Regular meetings within the Gastro II department (Clinical Operations)
- Monthly reporting to the Head of Clinical Research
- Support for the Head of Clinical Research in preparing and updating clinical development plans
- Cross-functional support in the clinical assessment of research and/or study proposals, development offers, and Go/No-Go decisions in clinical development
- Organization of and participation in Steering Committee meetings with development partners
- Participation in new patent applications
- Preparation of cross-functional presentations for senior management (e.g., deep dives, global program updates, phase transitions)
- Participation in reviewing the clinical sections of regulatory submission dossiers, documents for scientific consultations (e.g., Scientific Advice, PIP, benefit dossier, etc.), or orphan drug applications in consultation with the Head of Clinical Research
- Participation in coordinating and drafting responses to clinical deficiency letters in regulatory procedures in consultation with the Head of Clinical Research
- Participation in the creation and revision of SOPs in the field of Clinical Research
- Attendance at national and international congresses in the field of gastroenterology/hepatology
- Maintaining contact with clinical key opinion leaders in gastroenterology/hepatology
