Cross-Functional Toxicologist, Director

Cross-Functional Toxicologist, Director

Ascendis Pharma

Hellerup, Denmark

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.

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.