Medical Lead in Clinical Research (m/f/d)

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:

Your tasks

Serves as medical lead (ML) for the company-sponsored clinical trials and development programs. Responsible for guiding the clinical development strategy and ensuring the scientific integrity of clinical trials. ML collaborates with Clinical Research teams and serves as a key liaison between Clinical Research and Global Safety teams. ML manages all medical aspects of clinical trials and contributes to the development of trial documents. ML drives execution for assigned projects in collaboration with Clinical Research teams and other cross-functional stakeholders.

Key Responsibilities

• Provides medical input to Clinical Trial Protocol, Investigator’s Brochure, Informed Consent Form, Independent Data Monitoring Committee Charter, Statistical Analysis Plan, Medical Monitoring Plan, Clinical Trial Report, Clinical Trial Overview Statements and other clinical trial documents
• Provides medical risk assessment for activities related to clinical trials and development programs
• Performs oversight for clinical trial medical monitoring activities outsourced to CROs
• Point of contact for sites and clinical trial teams with medical questions
• Point of contact for questions on Clinical Trial Protocol with regard to inclusion and exclusion criteria, concomitant medications
• Collaborates with various departments, including Global Medical Affairs and Global Safety/Pharmacovigilance to provide medical input for the development of patient-centric benefit-risk profile assessment strategies for developmental compounds
• Supports data analysis and interpretation of collected data to assess the efficacy and safety of the compound/intervention, including statistical evaluation and comparison to predefined endpoints
• Interprets clinical trial medical data for Clinical Trial Reports and submission documents
• Supports final report preparation including compiling findings into a comprehensive Clinical Trial Report that outlines the methodology, results and conclusions of a clinical trial and which will be used for regulatory submissions
• Reviewer of regulatory submissions based on clinical trial results with focus on efficacy, including preparing and submitting necessary documentation to regulatory authorities, such as the FDA or EMA
• Supports Global Safety with medical expertise in the review of adverse events and safety issues, as requested
• Provides support in the review of scientific publications (abstracts, presentations, and manuscripts)
• Supports review of concepts for investigator-initiated studies
• Contributes to company-internal process improvement initiatives (e.g. SOP updates)

Your qualification

• Physician / medical license holder
• A minimum of 5 years of clinical development research, 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 clinical evaluation projects including the development of Clinical Trial Protocols, case report forms, Informed Consent Forms and Investigator Brochures.
• Proactive team player, results-oriented, and striving to find optimal solutions in a collaborative team environment
• Self-organized, self-motivated, and able to work independently
• Proficiency in standard MS Office applications
• Excellent written and oral communication skills
• Proficient in English, advanced knowledge in German
• Ideally you should be willing to work at least 1 day/week in our Freiburg office. However, the position can also be fullfilled hybrid, with periodic meeting attendance at Dr. Falk Pharma GmbH Freiburg office (frequency to be agreed)

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.

HR department Dr. Falk Pharma GmbH Leinenweberstraße 5
79108 Freiburg im Breisgau