Director of Pharmacometrics
ProClinical is seeking a Director of Pharmacometrics to be based in Switzerland on a contract basis. This role will provide strategic and operational accountability and oversight on PK / 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. Interpretation of the results, considering POP PK models for pivotal studies and professional interactions with vendors is a given.
The role holder should work closest with the respective parties to improve probability of success for successful approvals of the assets. Presentation and communication skills to represent the companies interests towards agencies as key expert is expected.
- Provide strategic and operational guidance on PK / PD related topics for the development pipeline
- Manage projects and provide oversight and guidance related to planning, execution, interpretation and reporting of pharmacokinetics (PK) and pharmacodynamics (PD)
- Apply simulation methods to support dose selection, trial design, and Go/No-Go decisions
- Effectively partner with inter-disciplinary teams as well as external consultants to ensure proper conduct and reporting of clinical trials
- Participate in the preparation of reports/abstracts/manuscripts and regulatory documents
- Interact with regulatory agencies through written responses or face-to-face meetings, and participate in drafting responses to regulatory questions
Skills and Requirements:
- Post-graduate advanced degree in clinical pharmacology, pharmaceutical sciences, pharmacometrics, or equivalent with a minimum of 10 years of relevant experience related to PK/PD, experience with large molecules will be an asset
- Expertise to de-risk and targeted development by implementing state of the art pharmacokinetic/metric approaches
- Ability to summarize, communicate and present outcomes of PK/PD analyses into information that can be used by project teams and other stakeholders
- Thorough understanding of the basic principles of PK/PD (noncompartmental, compartmental, PBPK)
- Proficient in performing noncompartmental and compartmental PK/PD analyses.
- Understanding/ with modelling and simulation software and applications such as NONMEM®, PHOENIX® and ADAPT®.
- Thorough experience with relevant regulatory guidelines and track record of MAA/BLA/NDA submissions
- Attention to detail, ability to work under deadline pressure
- Capacity to work independently with minimal supervision in a matrix environment
- Excellent oral and written skills required in English (French would be an 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 Theodora Savlovschi-Wicks on +44 203 7520 314 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 Franc160000 - Swiss Franc161000 per annum
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