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 CROs 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-or visit our website

A note torecruiters:

Wedo notallowexternalsearchparty ofcandidateswithoutwrittenpermission from the Ascendis PharmaHR team(specificallyfrom: TalentAcquisitionPartner or Human ResourcesDirector) is .

Required Experience:

Director