Your mission

• Collaborates cross-functionally internally and with vendors.
• Ability to ensure highest quality safety management at aspiring Biotech company.
• Leading and mentoring of direct reports and peers on all safety related topics.
• Manages the safety vendor and ensures adequate sponsor oversight of all tasks outsourced.
• Writing and maintaining Safety SOPs / Templates and forms.
• Ensuring inspection readiness and internal Lead in Safety inspections.

Your profile

• Advanced degree within life sciences, Pharmacy or medicine (MD or med. vet.) preferred.
• Minimum of 10 years in Clinical Development of which minimum of 5 years in Clinical Safety. (experience in therapeutic area of Oncology / Immuno-Oncology preferred).
• Significant experience in strategic safety (signal management, risk assessments, interactions with regulatory authorities) data review, safety reporting, authority interactions (US and EU).
• Profound knowledge of all regulatory requirements in the area of GCP and Clinical safety.
• Managerial skills to build and manage the Clinical Safety department.
• Experience with safety databases (preferred ARGUS).
• Proficiency in English, excellent writing skills.
• Full-time availability with, ideally, 3-days per week presence in the office.

Why us?

• Impact & Growth – Be part of a dynamic, goal-oriented company where your contributions truly make a difference.
• Innovation – Work on groundbreaking immuno-oncology therapies with a mission-driven team.
• Collaboration & Culture – Enjoy a multicultural, open, and appreciative work environment and direct communication channels.
• Additional Benefits – Competitive compensation, professional development opportunities, and more!

 
Join us in shaping the future of cancer therapy!

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!