Senior Clinical Project Pharmacologist

Senior Clinical Project Pharmacologist

Idorsia Pharmaceuticals

Allschwil, Switzerland

As a functional expert within a small, innovative group, you will play a pivotal role in advancing our clinical development programs. In this highly collaborative environment, you will provide strategic guidance on pharmacokinetics (PK), pharmacodynamics (PD), and drug interactions to ensure the successful progression of our drug pipeline. If you are passionate about making a meaningful impact and thrive in a hands-on, collaborative setting, we’d love to hear from you.

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 present 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., (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 10 years’ industrial experience in clinical pharmacology;
• Proven track record of successfully representing Clinical Pharmacology in Health Authority meetings;
• 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).