Director, Preclinical Development (Oral Immunotherapy)

Director, Preclinical Development (Oral Immunotherapy)

Required Skills

Preclinical Development (Biotech/Pharma)

Regulatory Affairs (EMA/FDA/IND/CTA)

Oral Drug Delivery / Mucosal Immunology

Manufacturing

and Controls)

CRO Management

New Approach Methodologies (NAMs)

Job Description

Job Title: Director, Preclinical Development (Oral Immunotherapy)

Job Type: Full-Time (Contract-to-Hire)

Location: Hybrid, Berlin, Berlin, Germany

Job Summary

Are you passionate about pioneering the next generation of oral immunotherapy? Join our team as Director, Preclinical Development (Oral Immunotherapy) and take the helm of our cutting-edge MZI-001 platform. Reporting directly to the CEO, you will drive our preclinical program from concept to clinical trial application, ensuring innovative, animal-free approaches and robust regulatory compliance.

Key Responsibilities

• Lead all preclinical development activities for the patented MZI-001 oral immunotherapy platform, shaping scientific vision and execution.
• Design, implement, and optimize studies to generate comprehensive safety and efficacy data packages, leveraging the latest New Approach Methodologies (NAMs).
• Serve as the single point of contact for regulatory strategy and engagement, preparing and submitting dossiers for CTA/IND with both EMA and FDA.
• Oversee all Chemistry, Manufacturing, and Controls (CMC) activities, ensuring alignment with project milestones and regulatory standards.
• Strategically manage and coordinate activities with world-class CROs and research partners to deliver high-quality, timely results.
• Champion the transition of our oral drug delivery platform by integrating cutting-edge mucosal immunology concepts into preclinical designs.
• Foster a culture of scientific excellence and effective cross-functional communication within the organization, with a strong emphasis on clear, impactful written and verbal communication.

Required Skills and Qualifications

• PhD or equivalent experience in Immunology, Pharmacology, Biochemistry, or related life sciences field.
• Significant experience (8+ years) in preclinical development within the biotech or pharma sector, ideally with oral drug delivery platforms or immunotherapies.
• Expertise in regulatory affairs, including hands-on experience with EMA/FDA/IND/CTA submissions.
• Robust knowledge of Chemistry, Manufacturing, and Controls (CMC) procedures and requirements.
• Proven track record in managing CROs and interdisciplinary research collaborations.
• Experience employing New Approach Methodologies (NAMs) in preclinical development settings.
• Exceptional written and verbal communication skills. We care deeply about clarity, precision, and impactful communication.

Preferred Qualifications

• Experience advancing novel oral immunotherapy platforms from preclinical to clinical stages.
• Strong background in mucosal immunology or oral drug delivery science.
• Prior leadership roles in fast-paced biotech startups or scale-ups.

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