Pharmacometrician to Clinical Pharmacology, Ballerup

Can you take on the role as LEO's new expert within pharmacometrics?
If you have a solid background within mathematical modelling of physiological systems or specifically within pharmacometrics you now have the opportunity to take on the challenge of becoming LEO Pharma's new modelling and simulation expert. You will join a small team of experienced and highly skilled scientists working with modelling and simulation activities in the area of PK and PK/PD. LEO Pharma has launched an extremely ambitious 2025 strategy and you will play a key part in this journey.
Your role
You will join an international market leader within dermatology with focus on inflammatory skin diseases. We have a strong commitment to understand the underlying causes behind these diseases and how our candidate drugs influence these mechanisms. Your primary tasks will be to:

• Provide clinical pharmacology expertise into clinical development plans, including the design, conduct and interpretation of relevant clinical pharmacology studies, analysis of data using advanced PK/PD modelling and simulation methodologies, develop and help execute the regulatory strategy (e.g. IB/IND, end of phase 1/2, and BLA), perform data analysis, and assist in reporting clinical studies.
• Utilize modeling and simulation to support model-informed drug development, e.g. be pivotally involved in the hands-on analysis and interpretation of clinical PK/PD (exposure/response) data, integrating clinical trial simulation strategies and communicate the relevant risk/benefit implications to project development teams.
• To plan, execute and report larger M&S activities including population PK/PD models, disease models, statistical models, PBPK models, QSP models, clinical trial simulations, literature meta-analysis, and other state of the art quantitative techniques.
• Collaborate across multiple functions for the appropriate design of Phase I-III studies; contribute to the preparation of key documents including investigator's brochures, clinical study protocols, study reports, and regulatory documents.

A vital part of the job is also to keep yourself updated with new developments in the field of population kinetics and dynamics, including relevant regulatory legislation, guidelines and submission principles. You can look forward to joining LEO in one of the most exciting times in our history.

Your competencies
To succeed in this role you must hold an advanced degree in Engineering/Mathematics/Statistics or within Pharmaceutics/Pharmacy with focus on strong quantitative skills. Further you are interested and curious to learn and apply quantitative skills within the areas of PK and PD in clinical drug development. You have expertise with standard modelling and simulation software (NONMEM, Monolix, , R/SPlus, MATLAB, Berkeley Madonna, etc.) or with statistical software packages (R/SPlus or SAS) and knowledge of the use of modelling and simulation, and its role in drug development.

• You are able to communicate complex information of the PK & PK/PD modelling work effectively to a wide range of staff members and colleagues with different backgrounds.
• You are also known as someone who can function effectively in a highly matrixed environment, and actively and effectively participate in cross-functional project teams. As you will work closely together with multiple colleagues you must thrive on creating results via constructive collaboration.
• You may have worked in the pharma industry previously, and it is an advantage if your career has provided you with experience from authority interaction such as EoPh2 meetings and submission work.

About the Clinical Pharmacology department
You will join a well-functioning team of seven skilled scientist colleagues. We are responsible for PK, PK/PD, biomarker assessment and mode of action understanding of our drugs in all phases of clinical development. The department of Clinical Pharmacology is part of the Medical Sciences area, that embraces several aspects regarding clinical studies, descriptive characterisation and biological understanding of the drug action in human beings.

For further information, please contact Director Anders Hall +45 4173 6575.

Applications will be evaluated on a continuous basis until 28 Feb 2021.

We look forward to receiving your application.