Director of Pharmacokinetics job in Bern

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This vacancy has now expired. Please see similar roles below...

Proclinical is happy to advertise a new Director of Pharmacokinetics position for a global healthcare company that focuses on oncology and autoimmune diseases. The company employs more than 35,000 people world-wide and specialises in infusion and transfusion based technologies. This role is located in the company's Switzerland office.

Job Responsibilities:

Providing strategic and operational guidance on pharmacokinetics and pharmacodynamics related topics for the development pipeline.
Managing projects and providing oversight and guidance related to planning, execution, interpretation, and reporting of pharmacokinectics and pharmacodynamics.
Applying simulation methods to support dose selection, trial design, and decisions in moving forward.
Partnering with inter-disciplinary teams as well as external consultants to ensure proper conduct and reporting of clinical trials.
Preparing 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, disease progression, and exposure-response models.
Owning the respective SOPS in this respective 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 the pharmacokinetic and pharmacodynamic fields. Experience with large molecules an added benefit.
Expertise in implementing state of the art pharmacokinetic and pharmacometric approaches in order to target development.
An ability to summarize, communicate and present outcomes of pharmacokinetic and pharmacodynamics analyses into information that can be used by project teams and other stakeholders.
Experience with modelling and simulation software, and applications such as NONMEM, PHOENIX and ADAPT.
Experience with relevant regulatory guidelines and track record of MAA/BLA/NDA submissions.
Excellent oral and written skills in English, with adeptness in French being an added benefit.
The capacity to work independently with minimal supervision in a matrix environment.
Attention to detail, ability to work under deadline pressure.

To Apply:

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 Jacqueline Hohr on +44 3300528392 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.

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