Your mission

• Lead the non-clinical safety program for Visugromab, including leadership of the Non-Clinical Development Team.
• Represent the preclinical development function on the cross-functional program team and closely collaborate with other departments to ensure execution aligns with program strategy and objectives.
• Directly report to and work with the VP Preclinical Research & Translation Strategy to shape the overall preclinical development strategy and drive execution.
• Oversee and coordinate the execution of all preclinical studies in compliance with regulatory requirements, including GLP toxicity studies and bioanalytical assay development.
• Assist in the collection, analysis, and interpretation of preclinical study data, provide insightful recommendations, and contribute to the compilation of regulatory documents (such as IB, CTAs, BTDA, ODDA, SA), ensuring their completeness and accuracy.
• Proactively identify potential risks associated with preclinical development activities and formulate appropriate risk mitigating strategies to ensure project success.
• Serve as a liaison with external consultants, fostering productive relationships and leveraging external expertise to enhance preclinical development efforts.

Your profile

 

• Ph.D. in biology, immunology, pharmaceutical sciences, or a related discipline.
• A minimum of 5 years of industry experience at a biotech or pharmaceutical organization in preclinical research and development, preferably with a focus on biologicals and oncology.
• Prior exposure to formal preclinical development is required, including GLP-compliant toxicology studies and non-clinical bioassay development, preferably in a leading role, with a proven track record of preparing regulatory documents and demonstrating familiarity with regulatory requirements and guidelines.
• Demonstrated ability to independently assume responsibility and take initiative in addressing challenges with outstanding problem-solving skills, attention to detail, and adaptability.
• Eager to take a hands-on approach, demonstrating pragmatism and active engagement in all aspects of the work, essential for driving project success in a biotech environment. 
• Strong team-working skills, with excellent communication and organizational abilities.
• Excellent command of written and spoken English is essential; proficiency in German is considered a plus.

Why us?

• The opportunity to contribute to the development of a successful clinical program in oncology.
• A role in a pioneering environment as part of a dynamic biotech company on the rise.
• Open and appreciative corporate culture in a multicultural environment
• Creative working in driven and supportive X-functional teams
• Short communication channels
• Dynamic and goal-orientated environment
• Flexible work schedules with the option to work remotely.
• A secure and permanent employment contract.

About us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!