Director Program Safety Lead, Ascendis Pharma A/S / 1919

The Company
Ascendis Pharma A/S, is a fast-growing global biopharmaceutical company founded in Copenhagen, Denmark in 2007, committed to making a meaningful difference in patient´s lives. With locations in Denmark, Germany, the United States, the UK, Italy, Spain and France you join a growing international company.

Guided by their core values of Patients, Science, and Passion, using TransCon® drug development platform to fulfill the mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs. Today, Ascendis are advancing programs in Endocrinology, Rare Disease and Oncology. In addition, they collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets. Headquartered in Copenhagen, Denmark, operates from a modern office facility in Tuborg Havn, Hellerup. For more information about Ascendis Pharma read more: https://ascendispharma.com/

On behalf of our client, Best Talent is now searching for a Director Program Safety Lead to join this growing and dynamic team. 

The Team
As Director Program Safety Lead you join the Global Patient Safety Medical Science team consisting of 5 colleagues.  As a key member of the Ascendis Pharma team, you will play a crucial role in overseeing and managing patient safety activities for assigned programs. This is an exciting opportunity to work in a fast-paced environment, collaborating with cross functional, global teams working together to achieve extraordinary results. You will report to Head of Global Patient Safety Medical Science who is based in Germany. It is preferred that you will be working out of the Ascendis headquarters in Hellerup. It is therefore preferable that you live in Denmark, or in the Southern part of Sweden.

                                                  Director Program Safety Lead

• You take on responsibility for leading the safety strategy of the assigned program
• Dedication needed for aiming at excellence
• You collaborate with cross functional global teams
  
  

The Challenge
You will join Ascendis Pharma at an exciting time as they have already established a broad and advanced product pipeline, including FDA approved products.

As Director, Program Safety Lead, your responsibility will be to develop and successfully execute the safety strategy both within clinical trials and post- marketing for assigned products. You will apply your strong safety knowledge and skills in all aspects of surveillance, including signal detection and evaluation, authoring safety-related documents, and providing expert input into the safety monitoring and risk management strategies for clinical studies and programs.

You will achieve this through close collaboration with your colleagues in the Global Patient Safety team as well as counterparts in other functions. You will drive tasks and projects forward in leading roles and as participant.

Your key responsibilities will include:

• Lead all the safety activities for assigned drug programs
• Ensure compliance with global safety regulations, including EMA, FDA, and ICH guidelines
• Deep understanding of safety surveillance and signal detection
• Lead the preparation and review of safety documents such as PSURs, DSURs, and safety sections of regulatory submissions
• Collaborate with cross-functional teams to integrate safety data into clinical development plans
• Provide safety expertise during regulatory inspections and audits
  
  

Talent:
You hold a relevant academic degree – preferable as physician, pharmacist, or another healthcare professional with a doctoral qualification – and you have at least 8 years of experience in pharmacovigilance.
Furthermore, you have:

• In-depth knowledge of global pharmacovigilance regulations and guidelines
• Experience in preparing and reviewing safety documents regulatory submissions
• Proficiency in using pharmacovigilance databases and safety reporting tools
• Strong project management and organizational skills
• Excellent communication skills, both written and verbal
  
  

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 detail-oriented, proactive, and adaptable. Furthermore, this position requires flexibility and a few hours of overlapping working hours with colleagues based in Palo Alto, California.

It is vital that you are ready to take responsibility for leading safety surveillance activities in a cross functional setting. Your range of knowledge will also enable you to contribute more widely across the safety department.

You have shown to be highly organized with a strategic, proactive approach, and bring a pragmatic mindset to your work. A wide array of tasks will come your way and the ability to manage competing priorities, even with ambitious timelines, is important. 

Why Ascendis Pharma?
Ascendis Pharma offers an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will play a central role in the company´s strategy, working alongside highly skilled collegues to advance an innovative product pipeline. 

Due to the company´s international growth and structure you should expect approximately 20 travel days per year. You should expect some evening meetings during the week.

Application
Best Talent is managing the recruitment process and will handle your application confidentially. Please forward your application in English marked ”1919/Director Program Safety Lead” to job@besttalent.dk. Interviews will be conducted on an ongoing basis, so please apply as soon as possible.

Read more about Best Talent at www.besttalent.dk.