Clinical Transparency Lead

Location: 

Basel, BS, CH

 

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.

 

 

The Clinical Transparency Lead will be responsible for overseeing, managing, and executing transparency operational activities within the Regulatory Writing & Clinical Transparency Group. This highly independent role will partner with cross-functional stakeholders and vendors to plan and deliver clinical transparency projects in compliance with global health authority regulations and Idorsia policies and processes. Responsibilities include:

  • Oversee, coordinate, and manage the end-to-end process for anonymization and redaction of Idorsia documents, including documents made public under European Medicine Agency (EMA) Policy 0070, Health Canada Public Release of Clinical Information Policy, EU Clinical Trial Regulation and other policies or in response to external sharing requests
  • In close collaboration with Regulatory Writing & Clinical Transparency colleagues and cross-functional stakeholders in a matrix structure, ensure timely delivery of redacted / anonymized documents with high quality and in compliance with regulatory requirements and Idorsia policy and procedures
  • Oversee, coordinate, and manage activities related to delivering plain language summaries (PLS) of clinical trial results as required by law. Collaborate with internal and external stakeholders to establish an end-to-end process for delivering PLS
  • Lead or contribute to the creation and maintenance of policies, processes, templates, and best practices to meet current and future transparency requirements. Develop training and support change management for novel processes related to transparency activities
  • Provide vendor oversight to support transparency activities, as applicable
  • Train and/or mentor more junior staff, as required 
  • Act as Subject matter expert in data transparency 

 

 

Required qualification and experience:

 

  • Advanced degree in life sciences or related discipline (MSc/PhD or equivalent) 
  • 10+ years of relevant pharmaceutical/scientific experience, preferrable with 5 years of data transparency experience 
  • Advanced knowledge of global regulatory environment and submission processes, global clinical transparency regulations (e.g., EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation), and emerging principles/guidelines governing clinical transparency  
  • Redaction and anonymization knowledge, including solid understanding of data privacy regulations  
  • Experience in project management and process improvement 
  • Demonstrated interpersonal skills to build relationships with internal and external business partners 
  • Proven leadership experience on cross-functional projects with the ability to drive and manage organizational and team performance across multiple functions  
  • Innovative critical thinking; detail-oriented yet pragmatic problem-solving skills 
  • Strong ability to work under pressure, prioritize multiple deadlines and projects and meet challenging deadlines  
  • Excellent written and verbal communications skills 

 

 

 

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.