Job Detail

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 company, 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 600 highly qualified specialists dedicated to realizing our ambitious targets.

Job responsibilities

• Representing the toxicology department in research and development project teams


• Developing overall non-clinical safety strategies in conjunction with other research and development functions


• Design and direction of in-house pilot toxicity studies in rodents


• Designing and monitoring toxicity and safety pharmacology studies performed at CROs


• Interpreting study results and reporting them in an appropriate form (e.g. research reports, publications, presentations)


• Preparing and authoring integrative assessments of the non-clinical safety in regulatory documents (e.g. for IB, IND, IMPD, CTA, CTD, DSURs PSURs, briefing books)


• Representing Toxicology in interactions with competent authorities (e.g. National Health Authorities, FDA, CHMP)


• Responses to information requests from national and international agencies related to non-clinical safety studies


• Preparation of toxicological expert statements for impurities and excipients, cleaning validation, worker's safety


• Maintaining state of the art expert scientific, technical and regulatory knowledge in the area of toxicology and safety pharmacology


• Liaising with key consultants and scientists in the field
   

Candidate’s requirements

• University Degree in toxicology, pharmacy, human medicine, veterinary medicine, biochemistry, biology or any other natural science


• At least 5 years of work experience as a project toxicologist or study director of animal toxicity studies


• Knowledge of the regulatory environment regarding preclinical development of new drugs to support clinical development of all phases.


• Experience in authoring / reviewing of preclinical safety parts of regulatory documents (e.g. IB, IND, briefing books, NDA / MAA submission documents)


• Experience in communicating with Health Authorities


• Additional qualification as expert in toxicology (e.g. ERT) is desirable


• Knowledge about SEND compliant documentation is desirable


• Excellent command of English, both oral and written


• Ability to communicate effectively with a wide range of internal and external stakeholders


• Motivated and reliable personality and a committed team player

What Idorsia offers

• Exciting opportunities for development and professional growth within our dynamic organization: you can make a difference!


• A collaborative and solution-oriented environment


• An innovative and open culture in a truly multicultural environment


• A competitive salary and generous social benefits

Work Location: Allschwil

Country: Switzerland

Business Area: Preclinical Development

Schedule: Fulltime

Job Type:  Permanent

Job ID: 1448

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.