Specialist/Senior Specialist Pharmacometrician - Translational and Clin Dev

Ascendis Pharma A/S; Gentofte Kommune; À distance; DKK 900 000 - 1 300 000; Plein temps

Résumé du poste

Ascendis Pharma is seeking a hands-on Specialist/Senior Specialist Pharmacometrician to lead model-informed drug development across translational and clinical programs. You will apply PK/PD modeling, simulation, and exposure–response analyses to inform dose selection, trial design, and regulatory strategies.

The role offers broad ownership, cross-functional collaboration with global teams, and the opportunity to translate quantitative insights into actionable recommendations.

Qualifications

• PhD or MSc in pharmacometrics, pharmaceutical sciences, pharmacokinetics, mathematics or related quantitative discipline.
• Hands-on experience with PK/PD modeling and model-informed drug development.
• Experience with regulatory submissions is desirable.

Responsabilités

• Develop model-informed drug development strategies for translational and clinical-stage projects.
• Shape regulatory strategy and represent pharmacometrics in global health authority interactions.
• Inform dose selection, trial design, regulatory strategy, and lifecycle decisions via PK/PD modeling and simulations.
• Translate quantitative results into clear recommendations to teams and external partners.
• Plan, document and report analyses to internal quality standards and submission requirements.
• Strengthen methods and reporting capabilities within the department.

Connaissances

NONMEM

R

Pharmacometric analyses

Formation

PhD in pharmacometrics or related quantitative field

MSc in pharmacometrics or related quantitative field

Outils

LaTeX

Git

Description du poste

Are you passionate about pharmacometrics and model-informed drug development? Do you have experience with translational and clinical population PK/PD modeling and support of regulatory submissions?

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

We are looking for a hands-on pharmacometrician who combines scientific excellence with strategic thinking and wants broad ownership across programs.

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.

Our Pharmacometrics Department supports every asset in the Ascendis portfolio and acts as a strategic partner throughout development, from innovation and early research through translational and clinical development, regulatory submissions, and life cycle management. Each pharmacometrician contributes directly to development strategy and portfolio decisions.

We are seeking an experienced hands-on Specialist/Senior Specialist Pharmacometrician who can address complex development questions and translate quantitative insights into actionable recommendations. You will apply model-informed drug development in rare diseases, where quantitative methods can directly inform trial design, dose selection, and evidence generation in small patient populations. You will gain exposure across translational and development stages and contribute to projects throughout the portfolio, providing broad visibility and influence within the company.

This is an exciting opportunity to work in a fast-paced, dynamic environment and collaborate with cross-functional, global teams working together to achieve extraordinary results. You will work both independently and in close collaboration with colleagues in Pharmacometrics, global project teams, external partners, and consultants. You will be joining the growing Pharmacometrics Department and report directly to Kristin Carlsson Petri, Senior Director and Head of Pharmacometrics, who is based in Hellerup. You will also be based in Hellerup. The team includes in-house pharmacometricians, a pharmacometrics programmer, and external consultants working remotely.

Your key responsibilities will be to:

• Develop model-informed drug development strategies for translational and clinical-stage projects and ensure optimal use of pharmacometric methods to inform trial and program design.
• Shape regulatory strategy and represent pharmacometrics in global health authority interactions.

• Inform dose selection, trial design, regulatory strategy, and lifecycle decisions through population PK/PD modeling, simulation, exposure–response analysis, and quantitative benefit–risk assessment.
• Translate quantitative results into clear recommendations to project teams, senior management, health authorities, external partners or organizations.
• Plan, document and report pharmacometric analyses in accordance with internal quality standards and global regulatory submission requirements.
• Strengthen departmental methods, standards and capabilities through peer reviews, knowledge sharing, and continued development of the department’s modeling and reporting environment.

Qualifications and Skills:

You hold a PhD, MSc, or equivalent qualification in pharmacometrics, pharmaceutical sciences, pharmacokinetics, mathematics, engineering, or another relevant quantitative discipline. You have relevant experience with PK/PD modeling and model-informed drug development.

Furthermore, you have:

• Hands-on experience with NONMEM and R applied to population PK/PD model development, simulation, and model-informed drug development.
• Strong programming skills and technical expertise to organize, perform, document, and report pharmacometric analyses to submission standard.
• Experience with translational and clinical-stage analyses, including population PK, PK/PD, exposure-response, dose selection, and trial-design questions.

Additional experience that would be an advantage:

• Industrial experience supporting regulatory interactions or submissions, including knowledge of relevant FDA, EMA, and ICH expectations for pharmacometric analyses.
• Familiarity with LaTeX, Git and reproducible reporting workflows, or experience applying machine learning, artificial intelligence, or automation to pharmacometric workflows.

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 communicate complex quantitative findings clearly, work effectively across disciplines, and balance analytical detail with broader development objectives.
• You combine a strong quantitative background with biological and clinical understanding and collaborate effectively with scientists, clinicians, regulatory colleagues, and external partners. Your ability to share knowledge and contribute to common goals will be valued among colleagues.

Travel:

5–10 days per year.

Office:

Tuborg Boulevard 12, Hellerup, Denmark.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

For further information about the position, please contact Kristin Carlsson Petri, Senior Director and Head of Pharmacometrics at [e-mail].

You can learn more about Ascendis by visiting our website www.ascendispharma.com.

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team—specifically a Talent Acquisition Partner or Human Resources Director is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.