Principal Toxicologist

Zealand Pharma; Søborg; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Zealand Pharma A/S in Denmark is seeking a Principal Toxicologist to guide the safety assessment of our pipeline from discovery through clinical development. You will design, monitor and interpret non-clinical studies and strategies in close collaboration with multidisciplinary project teams, CROs and other stakeholders.

You will author toxicology sections for regulatory submissions (INDs, CTAs, NDAs/MAAs) and provide expert input to cross-functional teams, while leading investigations of

Qualifications

• Minimum 10 years of experience in preclinical drug development.
• Deep knowledge of global regulatory guidelines including ICH, FDA, and EMA.
• Experience authoring and reviewing regulatory submissions (IND, CTA, NDA/MAA).
• Extensive experience in toxicology study design and CRO management.
• Biotech/pharmaceutical development knowledge including antibodies or biotech modalities (advantage).
• Excellent communication and stakeholder management skills.

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 (INDs, CTAs, 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.
• Support risk assessment and benefit-risk evaluations with clinical and regulatory affairs.
• Contribute to due diligence activities and evaluation of external opportunities.
• Contribute to continuous development of nonclinical safety practices and internal guidelines.

Skills

Regulatory guidelines knowledge (ICH,

Education

DVM

Cand. Pharm

PhD in toxicology/pharmacology (advantage)

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.

For further information, please contact Senior Director, Peter Glerup at [e-mail].

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

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.