Director, Senior Clinical Project Scientist

Location: 

Allschwil-Basel Area, 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 will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in the Basel Area (Allschwil) 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 800 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for a Director, Senior Clinical Project Scientist to join our dynamic and motivated team !

 

Job Responsibilities

 

This is an opportunity to participate in or lead the entire range of scientific responsibilities at the trial project level, for compounds in clinical development, across multiple therapeutic areas.

  • Collaborates closely with the Clinical Project Physician on relevant project/program-related activities
  • Provides scientific input into project/program level documents such as the CDP, communication plans, IBs, briefing books for health authority meetings, PIPs, clinical overviews and summaries
  • Contacts clinical experts, organizes and contributes to expert meetings
  • Participates at meetings with health authorities
  • Develops a sound understanding of the science and medicine related to a trial, including competitive landscape
  • Perform literature reviews and ensure acquiring medical and scientific knowledge specific to the project/program needs
  • Provides scientific input to project/program-related medical monitoring activities
  • Participates in life cycle activities and life cycle meetings as appropriate
  • Represents the project/program along with the Clinical Project Physician at internal and external meetings
  • Contributes as needed to trial-level activities and train and mentor junior team members

 

Candidate Requirements

 

  • PhD, Pharm D, MSc or equivalent university degree in life or health science
  • Successful proven records of at least 3 years in a similar position
  • Extensive experience in a contract research organization (CRO) or pharmaceutical company in all aspects of the planning, setting up, conducting, closing, and reporting of phase II and III clinical studies from a scientific perspective
  • Experience in psychiatric or neurologic diseases would be an advantage
  • Previous leadership in independently authoring clinical study protocols, ICFs, scientific trial-related documents (e.g., study committee charters, CSR)
  • Previous scientific contribution to cross-functional trial documents (e.g., SAP), guidelines, CRFs
  • Solid experience with data review/medical monitoring
  • Previous program (project) level experience within a clinical development program for a compound including:
  • Scientific contribution to documents such as the clinical development plan (CDP), communication plans, IBs, briefing books for health authority meetings (e.g., pre-IND, pre-NDA, end of Phase 2, SAWP/CHMP), Pediatric Investigational Plans (PIPs), clinical overviews and summaries
  • Participation in life cycle activities for a compound
  • Demonstrated ability to organize and contribute to scientific discussions with external experts
  • Good knowledge of drug development and clinical trial process
  • Good knowledge of regulatory requirements/ICH guidelines (US and non-US)
  • Excellent organizational and problem-solving skills with the ability to work under pressure and meet short timelines
  • Inspires and convinces others, gaining agreement from people, lobbies and networks effectively with key stakeholders
  • Demonstrated ability to work independently in a fast-paced environment, to prioritize multiple competing tasks, to proactively address issues and demands
  • Fluent in written and spoken English

 

What Idorsia offers

 

  • Exciting opportunities  for development and professional growth within our dynamic organization
  • A collaborative and solution oriented enviroment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and benefits

 


Work  Location: Allschwil
Country: Switzerland
Business Area: Global Clinical Development - Therapeutic Areas Units
Schedule: Fulltime 
Job Type: Permanent 

Job ID : 2850

 

 

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 will be informed in greater detail in due course.

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, please note that 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.