Business Minded Application Manager - Clinical area

Are you passionate about making good applications even better? Do you have experience with ensuring alignment between business stakeholders and technical teams?

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

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, the United States, UK, Italy, France, and Spain.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate Application Manager to join our growing team. As a key member of the clinical product team in Global IT, you will play a crucial role in supporting our Clinical Trial Supplies and Clinical Operations business functions. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

We are a cloud-first, zero legacy system environment. You will have excellent development opportunities in a very flexible environment where “the way we do things here” is open for discussion. We are currently on a journey to implement agile methodology and a product-mindset in the ways we work.

You will be joining the newly established product team supporting our Clinical Trial Supplies and Clinical Operations business functions. The team currently consists of 6 dedicated team members, and as part of the team, you would work closely with Simon Rønne, Product Owner, on the functional side and report to Lene Larsen as your People Leader. You will be based in Hellerup, together with the rest of the team.

Your key responsibilities will be:

• Maintaining and improving our applications, which includes maintaining regulatory compliance (GxP) in an agile setting.
• Ensuring understanding of business processes and needs and translating these to technical requirements for the vendors and the team to implement.
• Work with the other members on the team to develop application roadmaps aligned with business and IT goals.
• Coordinating with cross-functional stakeholders such as IT infrastructure, QA IT, Software vendors, and support partners to ensure efficient delivery of applications changes.
• Be responsible for and drive system administration and technical support (e.g user administration and incidents). The role is focused on oversight and guidance for technical resources that will deliver, but in some cases will need to be hands-on.
• Creating and maintaining application documentation as per SDLC methodology and operational documentation such as SOPs, work instructions and user manuals.

Qualifications and Skills:
We know that talent can come in many shapes and forms. We expect you to have a Master’s degree, but which scientific field you’ll come from is secondary. Most important is that you are well versed in IT processes, and that you are passionate and focused on creating value for our business teams, enabling them to help patients.

Ideally you also have:

• 5+ years of experience as a system manager, application analyst, solution architect, validation manager - or equivalent experience from working directly within the Clinical area with a focus on applications.
• You have worked in a biotech, pharmaceutical company or consultancy catering to the pharmaceutical industry.
• Experience with maintaining Clinical applications such as CTMS, eTMF, IRT, etc.
• Deep Clinical business process knowledge, preferably within Clinical Operations and Clinical Trial Supplies
• Experience with GxP validation such as 21 CFR Part 11 and GAMP5.
• Experience preparing for and participating in GxP inspections from Regulatory Authorities.
• Knowledge about, and interest in agile methodology.

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.

To succeed in this role, excellent communication and collaboration skills are vital.

Travel: 5-15 days per year.

Office: Tuborg Blvd. 12, 2900 Hellerup

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 position or the company, please contact Simon Rønne on [email protected] or Lene Larsen on [email protected] or visit our website www.ascendispharma.com

Hellerup