Director Clinical Affairs

Topadur is a patient-centered, clinical-stage biotech company focused on developing disruptive therapies for age-related diseases. The Swiss company was founded in 2015 and has developed the DualTOP™ technology platform. The active ingredients based on it increase cGMP levels to stimulate microcirculation, enable tissue regeneration and prevent local oxygen deprivation. Topadur's R&D portfolio consists of promising development candidates in the fields of regenerative medicine, oncology, ophthalmology and medical aesthetics to enable longer and healthier lives. In October 2021, TOP-N53 was granted orphan drug status by the European Medicines Agency (EMA). The lead candidate TOP-N53 is currently in Phase IIa clinical development. Working location: Basel Area or Schlieren

Your responsibilities

• Lead and oversee the clinical development strategy for the CRM (Clinical Research Management) program of TOP-N53 and TOP-M119
• Study monitoring, collaboration with study centres and engagement with Key Opinion Leaders
• Drive the development and execution of clinical protocols, monitoring the progress of studies and making necessary adjustments to ensure successful outcomes.
• Analyse and interpret clinical trial data, providing insights and recommendations to support decision-making processes
• Selection, monitoring and coordination of CROs during the clinical trials, creating IB’s, patient information, Ethics application for clinical study and designing study protocols
• Ensuring compliance with ICH/GCP-Guidelines
• Provide medical expertise and oversight throughout all stages of clinical development
• Interface with regulatory agencies and health authorities to support product development activities from clinical development to pre-market launch

Your profile 

• Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD / PhD or MD is strongly preferred.
• At least 3 to 5 years experience in clinical research management with track record in clinical trial management and CRO management
• Working knowledge in the field of rare diseases is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• In-depth knowledge of clinical trial design, execution, and regulatory requirements
• Strong analytical and problem-solving skills, with the ability to determine appropriate actions based on data analysis
• Excellent communication and presentation skills, with the ability to effectively convey complex scientific concepts to diverse audiences
• Strong collaboration skills and the ability to work effectively with diverse teams from different departments
• Excellent project management skills, and familiar with digital project management tools
• A passion for making a difference in the lives of patients and a commitment to upholding the highest ethical standards

Your benefits

• a highly interesting role with a high degree of freedom
• working on projects, that really make a different in patient's life's
• short decision-making processes and flat hierarchies in a dynamic environment
• a competitive salary package

N: BattermanConsultingBaselAG