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Y-mAbs Therapeutics A/S, Hørsholm
Y-mAbs Therapeutics A/S is looking for an Associate Director, Quality Assurance in the area of Pharmacovigilance (PV) and Drug Safety, who will be part of a team of highly qualified and motivated colleagues.
It is our expectation that this person will establish QA processes to contribute to Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) compliance of the company operations.
- Contribute to development of the company Quality Management System and provide guidance in local and global requirements, as applicable to Pharmacovigilance and Clinical Drug Safety
- Maintain Quality oversight of Pharmacovigilance System Master File, pharmacovigilance SOPs, Safety Management Plans, Pharmacovigilance Agreements, and other relevant documents
Y-mAbs Therapeutics A/S, Hoersholm
Y-mAbs Therapeutics is establishing an in-house focus area of protein engineering within the CMC governance area. The focus area of protein engineering will support our growing pipeline of future product candidates. We are therefore looking for a candidate with both a strong scientific knowledge in the area and with an entrepreneur mindset to lead and grow this focus area.
The candidate will play a key role supporting the future lead candidate selection process moving identified targets to final development candidates. This encompass designing and directing the first antibody campaigns, based on immunizations or available sequence information, and collaborate on an optimal screening strategy throughout the lead selection process, based on structural and biochemical insight.
Unique Human Capital recruiting on behalf of Y-mAbs Therapeutics A/S in Hørsholm
Can you successfully lead the development and implementation of regional and global medical affairs strategies and plans?
Y-mAbs is a fast-paced, growing company in the process of expanding its organization to support the continuous growth and the exciting clinical pipeline with activities in both early and late-stage clinical development.
As Global Medical Affairs Lead at Y-mAbs you will drive the successful development and implementation of regional and global medical affairs strategies and plans, and serve as a bridge between R&D and local medical affairs and commercial activities. You will be responsible for tasks related to insight generation, evidence generation, data dissemination, scientific exchange, product and disease area training, compassionate use programs, market access initiatives, and collaboration with commercial and alliance partners.