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Medical Director

Exciting opportunity to join a dedicated Medical Team in global clinical development

 

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.

To support this journey, Y-mAbs is now looking for a Medical Director with solid experience in clinical development or clinical trials who is seeking to expand their experience and responsibilities in a company that strives for becoming the world leader in developing antibody-based cancer products that address clear unmet needs in oncology.

As Medical Director at Y-mAbs, you will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into regulatory documents and presentations. You will join an experienced and dynamic Medical team consisting of Medical Directors in Clinical Development, Clinical Drug Safety, Pharmacovigilance and US Medical Affairs. Together, they support the clinical development, regulatory approval, scientific engagement and successful launch of medicines.

You will report to the Senior Medical Director covering the anti-GD2 (naxitamab).

Your main tasks are:

  • Day-to-day medical oversight of ongoing clinical trials including directing study design, protocol development and execution of clinical research for pivotal cancer studies
  • Contributing to the overall medical strategy of the assigned clinical development programs and product pipeline as well as giving in-depth medical advice on potential new projects (internal and external)
  • Generating and reviewing clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access and commercialization of the compound(s)
  • Ensuring quality of all clinical documents (e.g. Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents)
  • Analyse clinical data
  • Participate in data monitoring committee meetings and data cleaning of clinical trial data
  • International networking and acting as medical expert developing advocacy through credible scientific discussions with external stakeholders (e.g. regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders (e.g. Research, Translation Medicine, Safety, Regulatory, Global Medical Affairs and Commercial)

Furthermore, you will serve as an internal resource, collaborating with all functions, providing medical input, guidance and training where needed. In addition, you will work across the other clinical programs where required, and support the responsible Medical Directors in overseeing the planning, execution and interpretation of clinical trials.

Your qualifications include a Master’s Degree in medicine (MD) combined with minimum +3 years of experience from the industry working in global clinical development being medical responsible for one or more clincial trials. Experience with oncology/hæmatology or a related field is an advantage, but not a demand. You have a strong teamwork attitude and are comfortable in working in cross-functional teams with medical, regulatory, saftety, data management and statistics. Your comunication and collaboration skills are excellent, and you speak and write English fluently.

You are a person with a can-do attitude and a positive and proactive approch. You have the ability to work independently with multiple tasks and under ambitious timelines in a fast-paced environment. Furthermore, you have great analytical skills and eye for details and good planning and problem handling abilities.

It is an exciting time to join Y-mAbs, as they have just had their first FDA approval and launch of the flagship pediatric cancer drug – Naxitamab, and further have a promising pipeline of several new cancer medicines which are both in early and late stage of development. This role will give the right candidate extremely valuable experience in the development, approval and launch of such medicines, and an opportunity to broaden their knowledge across multiple disease areas and indications.

Travelling: 20-25 days per year.

Domicile: You will be part of the Y-mAbs R&D Medical Department, based in the Y-mAbs Head Office in Hørsholm, Denmark.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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