Clinical Research - Head of Gastroenterology II (m/f/d)
Dr. Falk Pharma
Pharmaceutical Industry
Freiburg im Breisgau, Baden-Württemberg - Deutschland
Manager / Team Leader
Experteer Overview
In this role you lead company-sponsored clinical trials in functional GI and GI motility disorders, guiding development strategy and ensuring trial scientific integrity. You will partner with Clinical Research, Safety, Regulatory, and Medical Affairs to drive project execution and cross-functional collaboration. You’ll oversee study organization, budgets, contracts, and key development documents, while engaging with senior leaders and external partners. This position offers the chance to shape therapeutic programs within a global, family-owned company and support impactful patient care.
Compensation / Benefits
- new work
- flexible working hours
- mobile working
- health and sports benefits
- canteen
- JobRad
Responsibilities
- Line management for organization/project management of clinical studies in Gastro II
- Transfer of project responsibilities to assigned staff
- Review/approve critical development documents (e.g., Clinical Trial Protocol, master ICF, SAP)
- Review/approve study budgets and contracts with CROs/central labs
- Conduct regular Gastro II department meetings; monthly reporting to Head of Clinical Research
- Support Head of Clinical Research in clinical development plans
- Provide cross-functional support for study proposals, Go/No-Go decisions in development
- Organize/participate in Steering Committee meetings with development partners
- Contribute to patent applications and regulatory submissions-related activities
- Prepare cross-functional presentations for senior management
- Review clinical sections of regulatory dossiers and respond to deficiency letters
- Create/Revise SOPs in Clinical Research
- Attend national/international gastroenterology/hepatology congresses
- Maintain connections with clinical key opinion leaders in gastroenterology/hepatology
- Your qualifications: Completed medical, scientific, or pharmaceutical degree
- A minimum of 5 years of clinical development research and project management experience within industry
- Knowledge in gastroenterology/hepatology beneficial
- Experience with development of Protocols, CRFs, ICFs and Investigator Brochures
- Regulatory knowledge for clinical trials
- Several years of management experience
- Proactive, team-focused, self-motivated, independent work
- Excellent written and oral communication
- Proficient in English and German
- Proficiency in MS Office
- Willingness to work 2–3 days/week in Freiburg office
Key requirements
- medical, scientific, or pharmaceutical degree
- min 5 years in clinical development research and project management in pharma/CRO
- regulatory knowledge for clinical trials
- several years of management experience
- English and German proficiency
- MS Office proficiency
- willingness to work in Freiburg 2–3 days/week
- experience with development documents (Protocols, CRFs, ICFs, Investigator Brochures)
- knowledge in gastroenterology/hepatology beneficial
Description
In this role you lead company-sponsored clinical trials in functional GI and GI motility disorders, guiding development strategy and ensurin…
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