Director - Head of Immunogenicity

Zealand Pharma; San Juan de Sumapaz; Presencial; COP 373.273.000 - 485.256.000; Jornada completa

Descripción de la vacante

A leading biotechnology company is seeking a Head of Immunogenicity to guide scientific strategy in immunogenicity assessment across clinical stages. The ideal candidate will have a PhD with 8–12 years of experience in assay development, specifically in ADA and NAb. You will lead and mentor a team while ensuring compliance with regulatory standards. Join an innovative environment that values teamwork, and contribute to advancing peptide-based medicines. Applications are open until January 10, 2026.

Formación

• 8–12 years’ experience in immunogenicity assessment in pharma/biotech.
• Proven expertise in ADA and NAb assay development.
• Strong understanding of regulatory expectations for bioanalysis.

Responsabilidades

• Lead development and validation of immunogenicity assays.
• Provide scientific guidance and mentorship to team members.
• Integrate immunogenicity insights into clinical study designs.

Conocimientos

Leadership in immunogenicity assessment

Expertise in ADA and NAb assay development

Cross-functional collaboration

Problem-solving mindset

Educación

PhD in immunology, biochemistry, or pharmacology

Herramientas

ELISA

MSD

cell-based assays

ligand binding platforms

Descripción del empleo

Does it excite you to work with immunogenicity science and translational bioanalysis, and do you have experience leading development and validation of anti‑drug antibody (ADA), neutralizing antibody (NAb) and quantitative ligand binding assays? 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 Head of Immunogenicity, you will set the scientific direction for Zealand Pharma’s immunogenicity strategy across discovery, non‑clinical and clinical stages. The role combines scientific leadership with formal people management, expanding capabilities in ADA/NAb and quantitative ligand binding assays while driving proactive immunogenicity de‑risking. You will partner closely with internal teams and Contract Research Organizations (CROs) to deliver high‑quality, decision‑enabling data and support regulatory interactions.

We Offer Exciting Responsibilities

• Lead strategy, development, validation and lifecycle management of ADA, NAb and quantitative ligand binding assays (e.g., ELISA, MSD, cell‑based assays)
• Provide scientific guidance, troubleshooting and quality oversight for laboratory activities; mentor and develop team members
• Establish, characterize and maintain critical reagents and controls; ensure assay robustness, comparability and data integrity
• Oversee method transfer, qualification and validation with Contract Research Organizations (CROs), including protocols, deviations and reports; ensure compliance with industry standards and regulatory expectations
• Drive immunogenicity risk assessment and documentation; contribute to responses and interactions with health authorities
• Integrate immunogenicity insights into study designs, clinical protocols and reports; prepare and present clear data summaries and visualizations to stakeholders

Your profile

Brings a collaborative, solution‑focused mindset and a passion for scientific rigor. Operates effectively in a matrix environment, balancing strategic planning with hands‑on problem solving. Communicates complex data clearly, and builds a strong culture of quality, learning and continuous improvement.

• PhD in immunology, biochemistry, pharmacology or related field, with 8–12 years’ experience in immunogenicity assessment in pharma/biotech
• Proven expertise in ADA and NAb assay development and validation, with experience in quantitative ligand binding assays
• Proficiency with ligand binding and cell‑based assay platforms for immunogenicity and quantitative analysis
• Demonstrated people leadership of scientists/technologists and effective cross‑functional collaboration
• Experience managing CRO bioanalytical activities, including transfer, qualification and validation, and associated documentation
• Strong understanding of regulatory expectations and industry guidelines for regulated bioanalysis, immunogenicity assessment, risk management and reporting

Your new team

Join the Immunogenicity team within Pharmacokinetics, Immunogenicity and Bioanalytical Sciences, partnering closely with Drug Metabolism and Pharmacokinetics (DMPK), Non‑Clinical Safety, Clinical Bioanalysis, and Pharmacokinetics/Pharmacodynamics (PK/PD) Modelling and Simulation. The team collaborates across functions to deliver decision‑enabling data and support Zealand Pharma’s portfolio.

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.

Apply

Interested in bonding with us? Then please apply no later than January 10, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying.

For further information, please contact VP, Bioanalysis & Pharmacokinetics, Carsten Boye Knudsen and [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 the discovery and development of peptide‑based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late‑stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a team in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com.