Senior Clinical Trial Scientist

Location: 

Basel City

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,000 highly qualified specialists dedicated to realizing our ambitious targets.

 

 

 

 

 

Required qualifications and experience. 

 

  • PhD, Pharm D, MSc or equivalent university degree in life or health sciences.At least 5 years of experience in clinical development in a CRO or pharmaceutical company.
  • Solid experience in planning, setting up, conducting, closing, and reporting phase II and III clinical studies from a scientific perspective.
  • Previous authoring/co-authoring of clinical study protocols, ICFs, scientific trial-related documents (e.g. study committee charters).
  • Previous scientific contribution to cross-functional trial documents (e.g., SAP), guidelines, CRFs.
  • Solid experience with data review/medical monitoring.
  • Previous contribution to scientific discussions with external experts.
  • Good understanding of cross-functional clinical trial team roles, responsibilities, processes, and deliverables.
  • Good understanding of the drug development process, trial-related regulatory requirements/ICH GCP guidelines.
  • Fluent in English (written and oral).
  • Good organizational, problem solving, and interpersonal and communication skills.
  • Ability to work independently and within a cross-functional team to prioritize and coordinate multiple competing tasks.
  • Ability to work under pressure and meet short timelines without compromising quality.
  • Results driven attitude and good sense of urgency.
  • Able to anticipate and proactively address issues and demands.
  • Analytical thinking and data and detail oriented.
  • Shares knowledge and expertise openly.
  • Effectively negotiates with key stakeholders to influence, convince, and gain their buy-in and agreement.
  • Thinks globally and has an appreciation and understanding of the big picture (e.g., competitor activities, potential implications and consequences of own activities and decisions).
  • Able to travel occasionally as required to fulfil responsibilities and tasks.

 

Responsibilities and Tasks.

 

  • Core member of the clinical trial team (CTT).
  • Collaborates closely with the Clinical Trial Physician (CTP) on relevant trial-related activities.
  • Develops a sound understanding of the science and medicine related to an indication and trial and performs literature searches as needed to keep knowledge up to date.
  • Main deliverables include the clinical trial protocol and related documents such as the ICF, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR.
  • Provides input into and reviews cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual.
  • Performs data review and medical monitoring during the conduct of the trial.
  • Coordinates/manages the study committees.
  • Provides scientific input into responses for IRBs/ECs and HAs.
  • Participates in discussions with external experts.
  • Trains the relevant functions and roles on the scientific aspects of the trial.
  • Contributes to cross-functional and clinical development initiatives and processes as needed.

 

Depending on level of experience, the CTS may have a senior title (Sr. CTS).

 

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.