Clinical Trial Physician Immunology (897384-GBA)

Location
Canton of Basel-Stadt
Salary
Competitive
Posted
20 Apr 2021
Closes
20 May 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, is looking for a Clinical Trial Physician based in Basel, Switzerland.

To be considered for the role, you must have an MD, strong experience working on pre-clinical and/or clinical projects within the Immunology therapeutic area, previous experience working on Phase I studies, and ideally professional experience within a pharmaceutical or biotech company.

The tasks and activities of the Clinical Trial Physician will be carried out in close collaboration with the study Clinical Trial Scientist, the Head of Clinical Sciences and pre-clinical functions.

 

Responsibilities

  • Providing the medical leadership internally for the trial activities assigned, through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area;
  • Work cross-functionally with pre-clinical functions in order to drive the development of molecules to clinical stage and in different indications;
  • Delivering the medical aspects of the Clinical Project Development Plan related to the indication and overseeing its implementation;
  • Contributing to the core medical/scientific information required in all clinical documents of the respective trial (e.g. protocols, core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high-quality documents;
  • Supporting the Clinical lead by contributing to global strategic development and providing evidence-based input to clinical project-related, strategic and regulatory documents;
  • Writing protocol amendments and other study related documents such as the Informed Consent Form (ICF), committee(s) charter(s), subject narratives and the Clinical Study Report (CSR);
  • Delivering medical oversight of studies (including safety, medical review of data during the trial, quality and performance of the trial);
  • Interpreting Clinical Trial data and present conclusions and action plan(s) to Clinical Development Management team;
  • Managing contacts with external Experts, National Coordinating Trainers (NCTs) and study site investigators;
  • Answering to trial-related EC/IRB and HA questions;
  • Developing a sound understanding of the science and medicine relating to the therapeutic area;
  • Developing a sound understanding of the complexity of global clinical development with an attention to methodological and ethical aspects of development, in the assigned therapeutic area;
  • Performing literature reviews and write position papers as necessary;
  • Delivering medical training to the study teams’ members and/or staff and protocol-related training to study sites;
  • Leading and coordinating the interactions with the study National Coordinating Trainers and provide support for the implementation of the study-specific patient training;
  • Being the primary contact for the study National Coordinating Trainers to collect reports, feedback, questions, concerns and escalated issues;
  • Scheduling and facilitating regular meetings with the National Coordinating Trainers;
  • Working closely with National Coordinating Trainers to ensure that each country /region hosts regular meetings with the study site's trainers;
  • Contributing to the development of process to collect feedback from study trainers for quality control reporting, in collaboration with the study teams;
  • Liaising with relevant regional and academic societies and relevant patient groups to ensure alignment of the training with current local educational guidelines;
  • Keeping abreast of training trends, developments and best practices in the therapeutic area;
  • Coordinating the adaptation and localization of the training material and supporting its implementation at the regional/country level;
  • Ensuring that all study trainers have access to the training platform, are trained on the use of the program, that their roles and locations are clearly defined and mapped;
  • Collaborating with the operational team to maintain the training platform with all training content in all languages, up to date FAQ, trainer newsletter, and any additional materials the study trainers need to be successful at supporting the patients.

 

Qualifications and Experience:

  • Valid Swiss residency/work permit and/or EU citizenship required;
  • Completed MD;
  • At least 2 years’ experience in clinical research in a Pharmaceutical and/or Biotech company or equivalent in Academia/hospital environments, with a strong focus on Immunology;
  • Previous experience being the link between pre-clinical and clinical teams by driving molecule development into clinical stage;
  • Excellent written and spoken communication skills in English;
  • Experience in patient education is a plus;
  • Good knowledge of drug development and clinical trial process based on previous experience;
  • Good knowledge of regulatory requirements/ICH guidelines;
  • Good organizational and communication skills, able to work as part of a team and independently;
  • Proven record of successfully engaging and interacting within a complex and challenging matrix organization as well as with all levels of seniority;
  • Results driven attitude and good sense of urgency;
  • Able to anticipate and proactively address issues and demands, solution oriented and hands-on;
  • Analytical thinking, data and detail oriented;
  • Shares knowledge and expertise openly.