Cross-Functional Toxicologist

Ascendis Pharma

Hellerup, Denmark

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 being responsible for 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, collaborate with cross-functional, global teams working together to achieve extraordinary results. You will work both independently and in close collaboration with the Pharmacology and Toxicology department, CMC and clinical teams as well as with external partners at CROs, CMOs and with consultants. You will be in regular contact with employees in both Denmark, Germany, and US.

You will be joining the Pharmacology and Toxicology Department consisting of passionate colleagues. You will report directly to Kristin Laura Abel, Senior Director, Head of Pharmacology and Toxicology, who is 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;
Non-clinical justification of DP and DS specification limits including input to regulatory documents;
Sponsor’s monitor for QSAR assessment reports and potentially for CRO-conducted non-clinical safety studies;
Set-up and maintain collaborative relationship with internal experts and at CRO’s and CMOs and participation 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. – and +3 years of experience from the pharmaceutical industry or a CMO.

It is a major advantage if you have knowledge of quality management systems and GMP.

Furthermore, you:

Are passionate about chemistry;
Have an academic mindset and eager to learn and apply new knowledge;
Have a strong quality mindset;
Can collaborate and communicate effectively with key stakeholders, and provide clear recommendations.

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:

Effective and an engaged communicator with strong interpersonal and collaboration skills;
Good in planning your daily work, keeping track of assignments and able to adjust to changing priorities;
Willing to work across multiple projects in our pipeline.

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