Clinical Research - Head of Gastroenterology II (m/f/d)

Your tasks 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 studies of clinical 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 coordination 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

Your qualification Completed medical, scientific, or pharmaceutical degree A minimum of 5 years of clinical development research and clinical study project management, or related clinical research experience within the industry (pharmaceutical, biotech, CRO) at an international (Europe, USA, Australia) level is required Knowledge in clinical development in gastroenterology and/or hepatology is beneficial Significant experience with evaluation projects including the development of Clinical Trial Protocols, case report forms, Informed Consent Forms and Investigator Brochures. Solid knowledge of regulatory requirements for conducting clinical trials Several years of management experience Proactive team player, results-oriented, and striving to find optimal solutions in a collaborative team environment Self-organized, self-motivated, and distract to work independently Excellent written and oral communication skills Professional in English and German Proficiency in standard MS Office applications Ideally you should be willing to work at least 2-3 day/week in our Freiburg office

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 If you have any questions, please do not hesitate to contact Sabine Aicher at personal@drfalkpharma.de or call 0761 1514-253. We look forward to receiving your application via our online portal.