As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for:
Clinical Project Manager Early Clinical Research - Pharmacology (m/f/d)
Partially working from home possible
Your tasks
- Strategic planning, execution, and oversight of international Phase I clinical trials in accordance with GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA), and internal SOPs
- Preparation, review, and approval of all relevant study documents in collaboration with external service providers
- Contract negotiations with external service providers (CROs, central laboratories) as well as planning and monitoring of study budgets and timelines
- Responsibility for risk management and sponsor oversight within the studies
- Analysis and interpretation of study results as well as review and assessment of clinical study reports
- Leading project-specific study team meetings
- Supporting the clinical research department with questions related to clinical pharmacology
- Providing input on strategic strategies for development programs, including collaboration with industry and academic partners
- Supporting the evaluation of development projects and assessment of new product candidates
- Supporting the preparation of regulatory submissions and handling regulatory inquiries on clinical pharmacology topics
- Contributing to quality assurance activities (creation and revision of SOPs; preparation and execution of audits)
Your qualification
- Completed medical, scientific, or pharmaceutical degree
- Several years of professional experience in the pharmaceutical industry in clinical development and clinical study project management, ideally in Phase I
- Experience in clinical pharmacology (pharmacokinetics, pharmacodynamics)
- Solid knowledge of regulatory requirements for conducting clinical trials
- Excellent knowledge of MS Office applications
- Excellent written and spoken English skills, basic german skills desirable
- Strong organizational skills, analytical thinking, and enjoyment of systematic work
- Flexibility and resilience
- Strong communication skills
- Independent and team-oriented working style
Your benefits
- Supportive, respectful and appreciative work atmosphere in a small, dedicated team
- Diverse learning culture and individual development opportunities
- International and growing family business with short decision-making processes, financial independence and long-term perspective
- New work, flexible working hours and mobile working
- Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
- Comprehensive onboarding and mentoring program