Cross-Functional Toxicologist, Director

Are you passionate about making a difference for patients by applying your strong scientific expertise within drug development?

If so, now is your chance to join Ascendis Pharma as our new Cross-Functional Toxicologist

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 Cross-Functional Toxicologist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in delivering timely and high-quality toxicological evaluations of CMC-related quality attributes to ensure patient safety and support regulatory interactions, clinical trials, and product registration.

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 work both independently and in close collaboration with your colleagues in the Pharmacology and Toxicology department, with CMC colleagues, clinical teams, with external partners at CROs, CMOs, and consultants. You will be in regular contact with colleagues in both Denmark, Germany, and US.

You will be joining the Pharmacology and Toxicology Department consisting of passionate colleagues. 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 Kristin Laura Abel, Vice President, Head of Pharmacology and Toxicology, who is located in Hellerup. You will also be based in our headquarters in Hellerup.

Your key responsibilities will be:

• Point of contact for CMC regarding cross-functional collaboration between non-clinical safety and CMC within your projects
• Safety input to CQAs and SDSs of our development products
• Safety evaluation of excipients, extractables and leachables, and endotoxin thresholds
• Calculation and documentation of PDE and OEL values and Occupational Health Categorization reports (OEBs)
• Non-clinical justification of DP and DS specification limits including input to regulatory documents
• Collaborating on QSAR assessment reports
• Set-up and maintain collaborative relationship with internal experts and CRO’s and CMOs and participate in quality-related inspections from regulatory authorities

Qualifications and Skills:
You hold a relevant academic degree – preferably a MSc or PhD in Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, Veterinary Medicine, or other Life Science area. A minimum of 5 years of experience on the above mentioned areas either from the pharmaceutical industry, as a consultant or a CMO is mandatory.

Based on your level of experience, the job level may be adjusted.

Furthermore, you:

• Are passionate about chemistry
• Have a strong scientific and quality mindset and are eager to learn and apply new knowledge
• Can provide clear recommendations, including on complex topics

Key competencies:
You are a strong team player, analytical, and have a can-do attitude. You thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you are

• An effective and engaged communicator with strong interpersonal and collaborative skills
• Good at planning your daily work, keeping track of assignments, and able to adjust to changing priorities
• A person who enjoys working on many different tasks, as the job covers all projects in our pipeline

Travel: 10-15 days per year.

Office: Tuborg Boulevard 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 Kristin L. Abel, Vice President, Pharmacology and Toxicology on +45-2444 8530 or visit our website www.ascendispharma.com

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.

Hellerup