Principal Toxicologist

Zealand Pharma A/S; Denmark; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

Zealand Pharma A/S is seeking a Principal Toxicologist to guide safety assessments from discovery through clinical development. You will design nonclinical strategies, oversee studies at CROs, and author regulatory toxicology sections for INDs, CTAs, and NDAs while collaborating with multidisciplinary teams.

You will bring a deep toxicology background, drive cross‑functional decision making, and support risk assessments and health authority interactions on a global scale.

Qualifications

• Requires Doctoral or veterinary degree with toxicology/pharmacology expertise.
• Minimum 10 years of experience in preclinical drug development.
• Strong knowledge of ICH, FDA, EMA requirements and regulatory submissions.

Responsibilities

• Lead toxicology strategies across development phases.
• Design and oversee nonclinical safety studies at CROs.
• Author toxicology sections of INDs/CTAs/NDAs/MAAs.

Skills

Toxicology expertise

Preclinical toxicology

Regulatory toxicology

IND/CTA/NDA submissions

Cross-functional collaboration

Study design & data interpretation

CRO management

Global regulatory guidelines (ICH/FDA/

Education

DVM/PhD in Toxicology/Pharmacology

Job description

Does it excite you to work with nonclinical drug development, and do you have experience with preclinical and regulatory toxicology? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position As Principal Toxicologist at Zealand Pharma, you will be guiding the safety assessment of our pipeline candidates from early discovery through clinical development. You will be responsible for planning, designing, monitoring, interpreting, and communicating non-clinical studies and strategies in close collaboration with multidisciplinary project teams, CROs, and other stakeholders. You will bring deep scientific expertise and strategic thinking to ensure our medicines are developed safely and efficiently according to international standards and expectations of health authorities worldwide.

We offer exciting responsibilities:

• Develop and lead toxicology strategies for assigned drug candidates across all development phases
• Design, monitor and interpret nonclinical safety studies conducted at external CROs
• Author toxicology sections of regulatory submissions, including INDs, CTAs, and NDAs/MAAs
• Provide expert toxicological input to cross-functional project teams and governance committees
• Lead investigation and mechanistic understanding of toxicological findings and their relevance for human safety assessment
• Support risk assessment and benefit–risk evaluations in collaboration with clinical and regulatory affairs
• Contribute to due diligence activities and evaluation of external opportunities
• Contribute to the continuous development of nonclinical safety assessment practices and internal guidelines

Your profile

You are a collaborative and curious scientist with a strong toxicological background who enjoys working in a dynamic project environment and is motivated by developing and driving nonclinical strategies and in generating high quality nonclinical data and dossiers.

Qualifications

DVM, Cand. Pharm or equivalent scientific degree (maybe with a PhD degree) within toxicology or pharmacology. Minimum 10 years of experience in preclinical drug development, preferably within the pharmaceutical or biotech industry. Strong knowledge of global regulatory guidelines including ICH, FDA, and EMA requirements and design and implementation of toxicology strategies for project development programs. Significant expertise in authoring and reviewing regulatory submissions (IND, CTA, NDA/MAA) and in nonclinical support of projects at regulatory interactions. Extensive experience in toxicology study design, conduct, interpretation and reporting and in managing studies outsourced at CROs. Knowledge within development of biotechnology-derived pharmaceuticals (antibodies, genetically modifying drugs and other modalities) and in biological assessment of medical devices is an advantage. Excellent communication and stakeholder management skills, with the ability to present complex data to cross‑functional teams

Your new team

The Department of Nonclinical Safety Assessment is an experienced dynamic team with a culture of strong collaboration and support, both within the team and with other disciplines including bioanalysis, pharmacology, regulatory and project management. The department currently comprises of 2 toxicologists. The department is responsible for non-clinical safety assessment activities supporting projects from early research through First-in-Human clinical trials and beyond.

Let's bond and be bold

We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture. Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

#LI-Onsite

Since our founding in 1998, Zealand Pharma has built a core expertise in the discovery, design, and development of therapeutic peptides. This expertise has led to an R&D pipeline of innovative investigational candidates designed to address a broad range of disease areas. We have four therapeutic focus areas: obesity, rare diseases, chronic inflammation, and type 1 diabetes. In obesity, our peptide capabilities place us in a unique position to address a vast global health challenge and positively impact hundreds of millions of lives. Within rare diseases, we have a long‑standing commitment to deliver new treatments to patients living with congenital hyperinsulinism and short bowel syndrome. For chronic inflammatory diseases, we are progressing peptide programs focused on high‑profile targets shown to be difficult to address with small molecules and antibodies. For type 1 diabetes, we aspire to change the management of this disease. Our strategy is to pursue global co‑development and commercialization partnerships that complement and extend our capabilities across the value chain to deliver new peptide therapies to people who need them.

About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late‑stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.