Director Clinical Affairs - Batterman Consulting
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
Our client
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
