Specialist/Sr. Specialist, Pharmacometrician - Maternity Cover

<p><em>Are you passionate about pharmacometrics and model-informed drug development (MIDD)? Do you have experience within clinical population PK/PD modeling and MIDD?</em></p><p><em>If so, now is your chance to join Ascendis Pharma as our new Pharmacometrician.</em></p><p><strong>Ascendis Pharma </strong>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. </p><p>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. </p><p><strong>We are seeking</strong> 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.</p><p>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). </p><p><strong>Your key responsibilities will be:</strong></p><ul><li>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</li><li>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</li><li>Interpret, summarize, and present data to project teams, senior management and external partners/organizations</li><li>Contribute to the development of internal modelling procedures and standard scripts</li></ul><p><strong>Qualifications and Skills:</strong></p><p>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.</p><p>Furthermore, <strong>you have:</strong></p><ul><li>Hands-on experience with NONMEM and R used in MIDD and population PK/PD model development </li><li>Strong programming skills and technical expertise to organize, perform, and report pharmacometric analyses in submission standard</li><li>Industrial experience with regulatory submissions including knowledge of FDA/ICH guidance related to population PK/PD modeling analyses</li></ul><p><strong>Key competencies:</strong></p><ul><li>You are a strong team player, analytical, and have a can-do attitude. </li><li>You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.&nbsp;&nbsp; </li><li>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. </li><li>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.</li></ul><p><strong>Travel: </strong>5-10 days per year.</p><p><strong>Office: </strong>Tuborg Boulevard 12, Hellerup, Denmark&nbsp;</p><p><strong>Apply now.</strong></p><p>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.&nbsp;&nbsp;&nbsp;</p><p>To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.&nbsp;</p><p><strong>For more details</strong> about the position or the company, please contact Kristin Carlsson Petri, Sr. Director and Head of Pharmacometrics, <a href="mailto:kcp@ascendispharma.com" rel="nofollow noreferrer noopener" class="external">kcp@ascendispharma.com</a>.</p><p><strong>You can learn more about Ascendis by visiting our website </strong><a href="http://www.ascendispharma.com" rel="nofollow noreferrer noopener" class="external">www.ascendispharma.com</a></p><p><em>Applications must be submitted in English and will be treated confidentially.</em></p><p>&nbsp;</p><p><strong>A note to recruiters: </strong></p><p>We do not allow external search party solicitation.&nbsp; Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed.&nbsp; If this occurs, your ownership of these candidates will not be acknowledged.</p>