(Sr.) Professional, Bioanalytical Operations

Ascendis Pharma A/S; Gentofte Kommune; Remote; DKK 700,000 - 900,000; Full time

Job summary

Ascendis Pharma A/S in Denmark is seeking a professional to join the Bioanalytical Operations team. You will manage all bioanalytical operational aspects of clinical trials and collaborate with cross-functional teams in a fast-paced environment.

Based in Hellerup, you will report to Vice President Britta Bysted and coordinate with external labs, ensuring timelines, data transfer, and adherence to GCP standards throughout the trial lifecycle.

Qualifications

• Bachelor's degree in natural science or nursing/lab technician background with 5+ years in pharmaceutical drug development.
• Strong insights into GCP.
• Experience with planning and executing clinical trials and related documentation.
• Proven track record with external vendors (special and central laboratories).
• Strong IT skills.

Responsibilities

• Responsible for all bioanalytical operational aspects of clinical trial conduct on assigned projects according to trial timelines and priorities.
• Manage logistics and timelines for execution of bioanalytical sample analysis, from sample collection and processing, shipment, testing, data transfer, including sample tracking, reconciliation, and final sample disposition.
• Represent our area in the cross-functional trial teams, working closely with clinical operations, data management, clinical trial supplies among others.
• Support bioanalytical outsourcing activities in close collaboration with outsourcing department, including study-specific contract set-up, management of POs and invoices, and relevant communication with vendors.
• Provide input, review and approval, where applicable of relevant sections in study-related documents i.e., protocols/ICFs, data transfer specifications, central lab SOWs, laboratory manuals, SOPs, assay performance, bioanalytical reports, etc.
• Contribute to development and continuous improvement of bioanalytical operational processes and supporting documentation

Skills

GCP knowledge

Clinical trial planning

Vendor management

Bioanalytical operations

IT skills

Education

Bachelor degree in natural science

Nurse or laboratory technician background

Job description

Are you passionate about bioanalytical operational aspects of clinical trials? Do you have experience within clinical trial planning, timelines, and working with special labs?

If so, now is your chance to join Ascendis Pharma as our new employee in Bioanalytical Operations.

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 Professional to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in all bioanalytical operational aspects of clinical trial conduct. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Bioanalytical Operational Team in the Clinical Pharmacology & Bioanalysis area, based in our office in Hellerup. We are a well-functioning area, we treat each other with respect, and we never forget to bring a sense of humor to work. You will report directly to Vice President Britta Bysted.

Your key responsibilities will be:

• Responsible for all bioanalytical operational aspects of clinical trial conduct on assigned projects according to trial timelines and priorities
• Manage logistics and timelines for execution of bioanalytical sample analysis, from sample collection and processing, shipment, testing, data transfer, including sample tracking, reconciliation, and final sample disposition
• Represent our area in the cross-functional trial teams, working closely with clinical operations, data management, clinical trial supplies among others
• Support bioanalytical outsourcing activities in close collaboration with outsourcing department, including study-specific contract set-up, management of POs and invoices, and relevant communication with vendors
• Provide input, review and approval, where applicable of relevant sections in study-related documents i.e., protocols/ICFs, data transfer specifications, central lab SOWs, laboratory manuals, SOPs, assay performance, bioanalytical reports, etc.
• Contribute to development and continuous improvement of bioanalytical operational processes and supporting documentation

Qualifications and Skills:

You hold a bachelor degree in natural science or are trained as a nurse, laboratory technician, or similar with at least 5 years' experience with pharmaceutical drug development. Perhaps you have worked as a sample manager, clinical trial associate, clinical trial manager, or in similar roles.

Furthermore,

you have:

• Strong insights into GCP
• Experience with operational aspects of planning and executing clinical trials, and related documentation
• Proven track record in working with external vendors, e.g., special and central laboratories
• Strong IT skills

Key competencies:

To succeed in this role, we expect you to be able to work independently, be open-minded, flexible, supportive, and detail oriented.

You are a strong team player with a flair for logistics, and you enjoy being organized and systematic in your daily work. You thrive in an informal, open environment where innovation and change are key. You are comfortable navigating cross-functional collaborations and driving alignment among stakeholders.

Travel

3-7 days per year.

Office

Tuborg Boulevard 12, Hellerup, Denmark

For more details

about the position or the company, please contact Britta Bysted, Vice President of Clinical Pharmacology & Bioanalysis, [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.