Associate Director, Program Safety Lead, Global Patient Safety Medical Science

Are you passionate about Patient Safety? Do you have experience within safety science?

If so, now is your chance to join Ascendis Pharma as our new Associate Director, Program Safety Lead.

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 Associate Director, Program Safety Lead to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in providing broad, hands-on support for safety strategy, safety document development, signal evaluation activities, and cross functional collaboration. 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 GPS Medical Science Team consisting of 8 colleagues, and report directly to Head of GPS Medical Sciencewho is based in Germany.You will be based in Hellerup.

Your key responsibilities will be:

• Contribute to the development and implementation of safety strategies for assigned products in partnership with Program Safety Leads and cross‑functional stakeholders.
• Support PSLs in day‑to‑day tasks, including data review, analysis, interpretation, and preparation of safety‑related deliverables.
• Work closely with Medical Assessment and Signal Detection Leads to ensure consistent medical oversight of safety data across clinical and post‑marketing sources.
• Provide strategic input for safety sections of key documents, ensuring clarity, medical accuracy, and alignment across teams.
• Support regular surveillance of safety data, including assessment of potential safety issues and escalation of emerging trends.
• Contribute to signal detection, evaluation, documentation, and follow‑up per applicable SOPs and regulatory expectations.
• Assist with the development, maintenance, and execution of signal detection and risk management plans.
• Draft and review safety‑related documents, including expedited reports, aggregate reports (e.g., DSUR, PADER, PSUR), labeling updates, investigator brochures, protocols, and clinical study reports.
• Provide analytical and writing support to PSLs for safety‑related assessments, summaries, and strategic documents.
• Ensure accuracy, consistency, and inspection‑readiness across all safety documentation.
• Support preparation and execution of Drug Safety Committee meetings, including agenda planning, review of materials, presentation support, and documentation and follow-up of actions.

Qualifications and Skills:

You hold a relevant academic degree – doctoral or master’s degree in medicine or pharmacy – and at least 8 years of experience within patient safety.

Furthermore, you have:

• Demonstrated experience in safety data analysis, signal evaluation, and medical writing.
• Excellent working knowledge of FDA and EMA pharmacovigilance regulations, ICH Guidelines, and other relevant global safety regulations and guidance documents.

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, we also expect you to be a strong communicator and have excellent organizational skills.

Travel: up to 20days per year.

Office: Denmark, Hellerup.

Apply now.

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.

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company, please contact Elian Khazneh, Head of GPS Medical Science ([email protected])

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 from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.