Senior Clinical Research Scientist

Genmab

Copenhagen, Denmark

Join Genmab as a Senior Clinical Research Scientist (CRS) and play a key role in implementing world-class clinical trials aligned with our global development strategy. As a lead or co-lead, you will oversee the execution of one or more clinical trials across different therapeutic areas and development stages, ensuring high-quality and timely deliverables.

You will be part of the Medical department and work closely with the Medical Director and cross-functional teams, contributing to the clinical development strategy while managing trial implementation.

This position reports to the Senior Director, Clinical Research Scientist.

Key Responsibilities Include

Contribute 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, contribute 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).
Participate 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.
Contribute 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.
Participate to training at Investigator meetings, CRO/CRA training, SIVs as warranted.

Requirements

Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience.
Master in Science /pharmacy or equivalent, preferably within medical, biological, or pharmaceutical sciences.
Prior oncology/hematology drug development experience is a plus.
Proven skills from working in a project oriented matrixed team environment.

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to 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

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