Director of Pharmacometrics
ProClinical is currently advertising on behalf of a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company is currently seeking a Director of Pharmacometrics to join their Swiss team.
The incumbent will provide strategic and operational accountability and oversight on pharmacokinetic (PK)/pharmacodynamic (PD) related topics for the development pipeline, including input to modelling. This expertise and input should essentially support the clinical development and Biostatistical team to anticipate and plan the best path forward for phase 1 programs, where limited information on the key PK parameters may be available.
- Providing strategic and operational guidance on PK/PD related topics for the development pipeline.
- Managing projecting and providing oversight and guidance related to planning, execution, interpretation and reporting of pharmacokinetics and pharmacodynamics.
- Applying simulation methods to support dose selection, trial design, and Go/No-Go decisions.
- Partnering with inter-disciplinary teams, as well as external consultants, to ensure proper conduct and reporting of clinical trials.
- Participating in the preparation of reports/abstracts/manuscripts and regulatory documents.
- Interacting with regulatory agencies through written responses or face-to-face meetings and participating in drafting responses to regulatory questions.
- Overseeing external vendors and critically reviewing analysis of population pharmacokinetic/pharmacodynamic, exposure-response, and disease progression models.
- Owning the respective SOPs in this area.
- Proactively building and maintain a network of experts and fit for purpose providers.
Skills and Requirements:
- A post-graduate advanced degree in clinical pharmacology, pharmaceutical sciences, pharmacometrics or equivalent.
- At least 10 years of experience relevant to PK/PD, with experience with large molecules an asset.
- An ability to summarise, communication and present outcomes of PK/PD analyses into information that can be used by project teams and other stakeholders..
- A thorough understanding of the basic principles of PK/PD analyses into information that can be used by project teams and other stakeholders.
- A thorough understanding of the basic principles of PK/PD, such as PBPK.
- Proficiency in performing noncompartmental and compartmental PK/PD analyses.
- An understanding of modelling and simulation software and applications, such as NONMEM®, PHOENIX® and ADAPT®.
- Demonstrable experience with relevant regulatory guidelines, and a track record of MAA/BLA/NDA submissions.
- Attention to detail, ability to work under deadline pressure.
- A capacity to work independently, with minimal supervision in a matrix environment.
- Excellent English oral and written skills, with French a desirable asset.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Joshua Godden on +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Swiss Franc0.00 - Swiss Franc140 per hour
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