Clinical Research Scientist

Clinical Research Scientist

Genmab

Copenhagen, Denmark

The Role

This position may serve in a lead or co-lead role in the implementation of a clinical trial(s) within a program in alignment with the global development strategy. Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist as indicated for ongoing clinical trial-related activities to provide high-quality and timely deliverables.

Responsibilities

• Lead or co-lead a less-complex clinical trial(s) within a program.
• Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist
• Assists to execute the clinical trial in alignment with the clinical development plan (CDP)
• Assists with the development of a trial protocol and to other study-related and regulatory documents
• Assists 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).
• Contribute to the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
• Participates in country/site selection, feasibility assessment and engage in KOL interaction
• Assists in the development of charters and provide support to coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, Adjudication and Safety Committees)
• Assists in the development and review of study plans and serve as a liaison to project teams and CROs
• Assists to prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted

Requirements

• PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
• Clinical research experience preferred.
• Prior oncology/hematology drug development experience is a plus
• Ability to work in a project oriented matrixed team environment
• Excellent oral, written and interpersonal (communication) skills
• Ability to travel to as needed

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!