The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.
Headquartered in Switzerland – a biotech-hub of Europe – Idorsia is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.
In this role you will have the unique opportunity to influence the development of compounds from pre-clinical stage until market authorization.
Job Responsibilities
* Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, ensuring study deliverables are met on time, on budget, and with the appropriate quality.
* Interprets, reports, and presents study results to Life Cycle Team, Development Team, and committees comprising members of Idorsia Senior Leadership.
* Provides expertise to the PK/PD section of protocol of phase IIb-IV studies.
* Authors clinical pharmacology development plans for one or more products.
* Authors modeling and simulation plans, conducting hands-on PK-PD, Pop PK-PD and related analyses.
* Participates in Health Authority meetings as CP representative and contributes to regulatory documents (e.g. IB, IND, Briefing Books, NDA, and other regulatory documents).
* Supports business development / due diligence activities as a clinical pharmacology representative.
Candidate’s Requirements
* Minimum PharmD degree level of education with a preference for PhD or MD level of education.
* At least 7-10 years industrial experience in clinical pharmacology.
* Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.
* Experience in conducting and interpreting clinical pharmacology studies and translation from preclinical to clinical studies.
* The ideal candidate will have experience in preparing and reviewing clinical pharmacology sections of regulatory submission documents, attending regulatory meetings as well as in developing the modeling and simulation plans and conducting PK-PD, Pop PK-PD analyses.
* Highly self-motivated and proactive with a scientific and pragmatic approach to problem solving.
* A team player with well-developed interpersonal and communication skills; able to communicate effectively within a complex matrix organization with internal stakeholders at all levels of seniority as well as external contact persons.
* Very good English knowledge (oral/written).
What Idorsia offers
* Exciting opportunities for development and professional growth within our dynamic organization.
* A collaborative and solution-oriented environment where you can make a difference.
* An innovative and open culture in a truly multicultural environment.
* A competitive salary and generous social benefits.
Business Area:
Global Clinical Development & Medical Affairs; Clinical Pharmacology
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