Specialist/Associate Director, Pharmacometrician

Specialist/Associate Director, Pharmacometrician

Ascendis Pharma

Hellerup, Denmark

Description:

We are seeking a passionate, and experienced hands-on Pharmacometrician to join our growing Pharmacometrics Department, which covers all phases of drug development in Ascendis Pharma. Your strong skills within R programming and NONMEM modelling will be important assets for our team. As our new Pharmacometrician you will contribute to advancing drug candidates across Ascendis Pharma’s portfolio, from non-clinical to clinical development, including support of regulatory interactions and life cycle management. You will contribute to peer-reviews across the product portfolio and knowledge sharing in the Pharmacometrics Department, as well as contribute to the development of our pharmacometrics modelling environment (Metworx) and further development of our scripted reporting.

You will work both independently and in close collaboration with the rest of our Pharmacometrics Department, in cross-functional teams, and with external partners and consultants, being responsible for planning, performing, and communicating pharmacometric analyses. Furthermore, your role will include coordination of the pharmacometric activities for selected projects, including strategy development and close collaboration with the project team.

Your key responsibilities will be:

• Develop MIDD strategies and serve as subject matter expert for drug development projects and ensure optimal use of pharmacometric methods to optimize trial and program design
• Execute population PK/PD modeling and simulation analyses to support project decision-making and regulatory interaction, including producing analysis reports compatible with global regulatory submission requirements
• Interpret, summarize, and present data to project teams, senior management, and external partners/organizations, at conferences and in scientific papers
• Contribute to the development of internal modelling procedures and standard scripts
• Maintain a current understanding of pharmacometrics methodology including MIDD

Qualifications and Skills:

• You hold a relevant academic degree, preferably a PhD (or equivalent) within pharmacometrics or pharmaceutical/pharmacokinetic/biological/mathematical science and 5+ years of experience within PK/PD modeling.

Furthermore, you have:

• Hands-on experience with NONMEM and R used in MIDD and population PK/PD model development
• Strong programming skills and technical expertise to organize, perform, and report pharmacometric analyses in submission standard
• Industrial experience with regulatory submissions including knowledge of FDA/ICH guidance related to population PK/PD modeling analyses
• Familiarity with LaTeX and Git, as well as knowledge of the use of machine learning and artificial intelligence within pharmacometrics is a plus

Key competences:

You are a strong team player with a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment. To succeed in this role, we also expect you to be a highly proactive and analytical individual with a strong scientific background who enjoys challenges and working in a friendly, collaborative, and quickly developing organization. You have a strong mathematical background in addition to biological understanding and the ability to interpret, summarize, present, and communicate efficiently with scientists from other disciplines as well as clinicians. As you will be working on various tasks in different projects in parallel, you work in a structured way and have a high quality-oriented mindset with the right level of details while keeping the overall picture in mind. Your ability to share knowledge and contribute to common goals will be valued among colleagues.