Senior Clinical Pharmacologist

Idorsia Pharmaceuticals

In this role you will have the unique opportunity to influence the development of compounds from pre-clinical stage until market authorization.

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 llb-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

Minimum PharmD degree level of education with a preference for PhD or MD level of education
At least 7-10 years industrial experiences 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)

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