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Senior Clinical Research Scientist

The Role 

Genmab is looking for an experienced and dedicated Senior Clinical Research Scientist to be part of our Medical team.

As Clinical Research Scientist, you will be part of a dedicated team in US and DK and will constitute with your knowledge and experience in overseeing and developing clinical projects.

You will actively be working one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. This may include clinical trial implementation, oversight of all aspects of clinical development working closely with the Medical Director, and other cross-functions to provide high-quality and timely deliverables.

We are looking to fill this position in Denmark and the Senior Clinical Research Scientist will report to Senior Director, Clinical Research Scientist, US.

 

Responsibilities

  • Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds

  • Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted) 

  • Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP) 

  • In collaboration with the Medical Director, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s) 

  • Participates in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities)

  • Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis 

  • Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction 

  • Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees) 

  • Participate in the development and review of study plans and serve as a liaison to project teams and CROs 

  • Provide input for the development of publications in coordination with Scientific Communications 

  • Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted 

 

Requirements

  • Master’s degree in pharmacy, biology, or other related discipline area. PhD degree is preferred

  • Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience   

  • Prior oncology/hematology drug development experience is a plus

  • Proven skills from working in a project oriented matrixed team environment 

  • Excellent English skills, oral and written  

 

Moreover, you meet the following personal requirements:

  • Take initiative, enjoy working in a team, and inspire others with your enthusiasm

  • Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals that are important for the team and our organization.

  • An independent work-approach and good at building solid professional relations to collaborators as well as proven skills from working in a project oriented matrixed team environment

  • Thrive in a dynamic and fast paced environment

Degrees of interest: Master’s degree in pharmacy, biology

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