SpecialistAssociate Director, Pharmacometrician
SpecialistAssociate Director, Pharmacometrician
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1 Vacancy
Job Description
Are you passionate about pharmacometrics and model-informed drug development (MIDD) Do you have experience with population PK/PD modeling and MIDD
If so now is your chance to join Ascendis Pharma as our new Pharmacometrician.
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.
At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
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 Pharmas 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.
Travelling: 5-10 days per year.
Place of work: Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup just north of Copenhagen with a view of the harbor the canals and the sea.
Apply now. Applications will be evaluated when received so please apply as soon as possible. All applications must be submitted in English and are treated confidentially.
For more details about the job or the company please contact Head of Pharmacometrics Kristin Petri at Or visit our website
Required Experience:
Director
Employment Type
Full-Time
