Specialist/Sr. Specialist, Pharmacometrician

Specialist/Sr. Specialist, Pharmacometrician

Ascendis Pharma

Hellerup, Denmark

Description

Are you passionate about pharmacometrics and model-informed drug development (MIDD)? Do you have experience within clinical population PK/PD modeling and MIDD?

If so, now is your chance to join Ascendis Pharma as our new Pharmacometrician.

We are seeking a passionate and experienced hands-on Pharmacometrician to join our team covering for one of our colleagues going on maternity leave. In this temporary (1 year) position, you will be a key member of the Pharmacometrics Department and contribute to advancing drug candidates across Ascendis Pharma’s portfolio, with focus on the support of late clinical phases, including support of regulatory interactions and life cycle management. This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Pharmacometrics Department consisting of 9 colleagues, and report directly to Kristin Carlsson Petri, Sr. Director and Head of Pharmacometrics, based in Hellerup. You will also be based in Hellerup (just north of Copenhagen).

Your key responsibilities will be:

• Develop MIDD strategies and serve as subject matter expert for clinical stage 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;
• Contribute to the development of internal modelling procedures and standard scripts.

Qualifications and Skills

You hold a relevant academic degree, preferably a PhD (or equivalent) within 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.

Key competencies:

• You are a strong team player, analytical, and have a can-do attitude;
• You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key;
• 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;
• You have a high quality-oriented mindset with overview of the details, while keeping the overall picture in mind. Your ability to share knowledge and contribute to common goals will be valued among colleagues.