Clinical Trial Supply Manager/ Senior Clinical Trial Supply Manager

Ascendis Pharma; Hellerup; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ascendis Pharma is hiring a Clinical Trial Supply Manager to lead CTS activities across Phase 1-3 in a GMP/GDP-regulated setting. The role is based in Hellerup, Denmark, with collaboration across CMC, Trial Management, QA, IT, and Regulatory Affairs.

You will forecast supply of IMP, manage IRT setup and distribution from CMOs to sites, and ensure regulatory compliance while maintaining QMS/eTMF documentation. Travel is modest; English and Danish fluency is expected.

Qualifications

• Ideally, you hold a relevant academic degree in pharmacy or a related field and have at least 5 years of relevant experience in clinical trial supply management or a GMP/GDP-regulated environment.
• Proven experience in managing complex projects involving multiple internal and external stakeholders
• Strong understanding of regulatory requirements
• Proficiency in Microsoft Office
• Fluency in written and spoken English and Danish

Responsibilities

• Coordinating internal CTS trial meetings and activities and collaborating with internal departments incl. CMC, Trial Management, QA, IT, and Regulatory Affairs
• Forecasting, planning, and facilitating the supply of IMP for clinical trial supplies, including managing IMP Packaging and Labelling activities, packaging design, label text development, and planning of packaging runs
• Managing IRT setup, incl. IRT specification, UAT preparation and execution, Go-live and close-out, as well as managing IRT system changes after Go-live
• Managing IMP distribution from CMOs to clinical sites incl. direct-to-patient shipments and management of temperature excursions during storage at depots and clinical sites and during shipments
• Managing drug accountability activities, including returns, reconciliation and destruction
• Participating in meetings with CMOs, suppliers and vendors, trial teams and Investigator Meetings
• Maintaining documentation in the QMS and eTMF, including reviewing and preparing trial-related instructions and manuals

Skills

GMP/GDP compliance

Project management

Microsoft Office

Biopharma domain

Education

Bachelor's degree in Pharmacy

Job description

Are you passionate about clinical trial supply management? Do you have experience within GMP/GDP-regulated environments and managing complex clinical trial supply chains?
If so, now is your chance to join Ascendis Pharma as our new Clinical Trial Supply Manager.

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.

As Clinical Trial Supply Manager at Ascendis Pharma,you will be responsible for managing selected areas of the Clinical Trial Supply Chain in collaboration with internal and externally stakeholders. The Clinical Trial Supply (CTS) department comprises three closely collaborating teams: CTS - Coordination, CTS-IRT and CTS - Preparation & Handling.

We are seeking a passionate Clinical Trial Supply Manager to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in managing the clinical trial supply activities across Phase 1-3 studies. This is an exciting opportunity to work in a fast-paced environment and collaborate with cross-functional, global teams to achieve extraordinary results.

You will be part of a dedicated and highly experienced Clinical Trial Supply department comprising 12 colleagues. The position is based in Hellerup, Denmark.

Your key responsibilities will depend on your experience and may include:

• Coordinating internal CTS trial meetings and activities and collaborating with internal departments incl. CMC, Trial Management, QA, IT, and Regulatory Affairs
• Forecasting, planning, and facilitating the supply of IMP for clinical trial supplies, including managing IMP Packaging and Labelling activities, packaging design, label text development, and planning of packaging runs
• Managing IRT setup, incl. IRT specification, UAT preparation and execution, Go-live and close-out, as well as managing IRT system changes after Go-live
• Managing IMP distribution from CMOs to clinical sites incl. direct-to-patient (DtP) shipments and management of temperature excursions during storage at depots and clinical sites and during shipments
• Managing drug accountability activities, including returns, reconciliation and destruction
• Participating in meetings with CMOs, suppliers and vendors, trial teams and Investigator Meetings
• Maintaining documentation in the QMS and eTMF, including reviewing and preparing trial-related instructions and manuals

Qualifications and Skills:

Ideally, you hold a relevant academic degree in pharmacy or a related field and have at least 5 years of relevant experience in clinical trial supply management ora GMP/GDP-regulated environment.

Furthermore, you have:

• Proven experience in managing complex projects involving multiple internal and external stakeholders
• A strong understanding of regulatory requirements
• Proficiency in Microsoft Office
• Fluency in written and spoken English and Danish

Key competencies:

You are a collaborative and quality-focused team player with a structured and analytical approach to your work. You are adaptable, take ownership, and have a can-do attitude. You thrive in a fast-paced, informal environment where priorities may change and close collaboration is key.

Travel: 2–10 days per year

Office: Denmark, Hellerup, Tuborg Havn

For more details about the position or the company, please contact Sara Østergaard, Director Clinical Trial Supply PM Team at [e-mail].

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

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