Your mission

Your mission

• Provide medical support for assigned clinical program
• Lead clinical trial planning, set-up, launch, and execution from a medical perspective
• Support Investigators and trial sites for optimum recruitment
• Provide medical monitoring of ongoing trials
• Evaluate data from clinical trials in timely fashion (safety, efficacy, translational/biomarker), lead and conduct interim analyses
• Take a medical representative role in the clinical development and project management team and in interactions with regulatory authorities for assigned programs
• Support the CMO in all matters related to clinical trials
• Delegate pharmacovigilance activities as a representative of CMO
• Support Senior Management activities as required, e.g. regarding Board Meetings, Regulatory activities etc.

Your profile

• Depending on level of experience Director, Senior Director or VP level
• Medical doctor degree required, preferably with a board accreditation in oncology or at least 2-3 yrs of Oncology environment experience
• Solid background in the development of clinical study protocols and study reports including sound knowledge of clinical development methodology and study designs 
• Solid experience (track record of > 3 years in the industry) with notable oncology clinical development experience (preferably phase 2 and 3 development). Experience with registration trials is a “plus”. 
• Robust clinic-scientific background to understand biomarker and translational research results and ability to translate them into clinical context
• Strategic mindset, with previous experience in due diligence activities 
• Excellent medical writing
• Excellent presentation skills, including creation of high-quality ppt communication
• Sound knowledge of ICH-GCP and other relevant regulations/guidelines 
• Experience in interacting with regulatory authorities  (EMA and FDA a “plus”)
• Demonstrated expertise in ability to lead complex medical and scientific discussions and synthesize and communicate information clearly 

Why us?

• We plan to take an active, innovative novel immunotherapy concept foward to registration trials
• Creative working in X-functional teams
• Short communication channels
• Dynamic and goal-orientated environment
• Open and appreciative corporate culture in a multicultural environment
• Flexible working hours in the office and home office allow you to organize your time quite flexible.

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!