Associate Director/Director of Safety Surveillance, Y-mAbs / 1749
Y-mAbs is a commercial-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The company has a broad and advanced product pipeline, including, one FDA approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one pivotal-stage product candidate, omburtamab, which targets tumors that express B7-H3.
The mission is to become the world leader in developing antibody-based cancer products that address clear unmet needs in pediatric oncology. With the right partnerships and collaboration, they envision expanding their capabilities to treat adults, changing the course of cancer care and its outcome.
You will join the office location in the DTU Science Park in Hørsholm. This is the central hub for pre-clinical and clinical activities, and you will be very much at the heart of things. Read more on www.Ymabs.com
The Global Safety Evaluation and Risk Management team consist of 5 employees reporting to Sr. Director Eva Widebæk Rasmussen. The team is responsible for the surveillance and risk management of Y-mAbs medicinal products and work in close collaboration with the Post Marketing Pharmacovigilance team and the Medical team.
Y-mAbs is now looking for a highly skilled and engaged person, who will join the Global Safety Evaluation and Risk Management team and share the organization’s passion about being at the very forefront of biological cancer treatment.
If you want challenges, they are right in front of you. If you want to make a mark in the world for the better, you feel just like the rest of the employees.
Associate Director/Director of Safety Surveillance
- Making a real difference being at the forefront of biological cancer treatment
- You are ready to take on responsibility for leading safety surveillance
- Dedication needed for aiming at excellence
You will join Y-mAbs at an exciting time as they have already established a broad and advanced product pipeline, including one FDA approved product, DANYELZA® (naxitamab-gqgk), and one pivotal-stage product candidate, omburtamab, for which a BLAs and MAA have been submitted.
As an Associate Director/Director of Safety Surveillance your responsibility will be to develop and successfully execute the safety surveillance strategy both within clinical trials and post- marketing for assigned products. You will apply your strong safety knowledge and skills in all aspects of surveillance, including signal detection and evaluation, authoring safety-related documents, and providing expert input into the safety monitoring and risk management strategies for clinical studies and programs.
You will achieve this through close collaboration with your other 5 colleagues in the safety department as well as counterparts in other functions. You will drive tasks and projects forward in leading roles and as participant.
Your primary tasks will be to:
- Execute drug safety oversight for products in clinical development and in the post-marketing setting
- Perform medical assessment of reported adverse events
- Perform overall safety surveillance / risk management activities for Y-mAbs products
- Perform signal detection and analysis
- Prepare RMP
- Prepare aggregate reports e.g. DSUR, PBRER
- Contribute to the development and review of regulatory submission documents such as IB, protocols and BLA/MAA submission documents and labelling discussions
- Contribute and participate in external DMC(s)
- Contribute and participate in Y-mAbs’ Safety Committee(s)
- Contribute to responses to regulators
- Build and maintain drug safety expertise, understanding international safety regulations and guidelines
At Y-mAbs you will have ample opportunities for making your mark on the way the team develop and implement processes, systems and working practices. The team works in a relaxed, cooperative, non-formal atmosphere, and Y-mAbs expect you to speak your mind, engage in scientific discussions and strive to make a difference. They trust you to find the right way forward to handle challenges and tasks as the company transforms from the development stage to a commercial company. You will refer to the Sr. Director and Global Lead, Safety Evaluation and Risk Management.
It is vital that you are ready to take on responsibility for leading safety surveillance activities in a cross functional setting. Your range of knowledge will also enable you to contribute more widely across the safety department, including the development of Y-mAbs’s safety processes.
You have shown to be highly organized with a strategic, pro-active approach, and bring a pragmatic mindset to your work. A wide array of tasks will come your way and the ability to manage competing priorities, even with ambitious timelines, is important.
Ideally, your CV comprise:
- A relevant academic background such as a Masters/PhD in Medicine, Biology, Veterinary Medicine, Pharmaceutical Sciences or similar within natural sciences
- Have 5+ years of experience with Drug Safety
- Experiences with preparing aggregate reports e.g. DSUR, PBRER and Risk Management Plans
- Are knowledgeable about regulations applicable to drug safety
- Have prior experience leading product safety monitoring and risk management activities
You are collaborative by nature with a dedication needed for aiming at excellence. You also have the ability to drive things forward independently. You are used to navigate in a complex setting with multiple stakeholders, internally and externally. This also include working with CROs.
You are motivated by having a high impact position and you utilise your high level of energy and can-do attitude to proactively handle the various tasks at hand. You are keen on working in an entrepreneur environment and you are of course proficient in English, both written and verbal.
Best Talent is responsible for the recruitment for this position at Y-mAbs and review your application on a confidential basis. Forward your application including your CV attention ”1747/ Associate Director” by way of e-mail to email@example.com You can read more about Best Talent at www.besttalent.dk.