Senior Clinical Research Scientist, Solid Tumor Team

Genmab

Copenhagen, Denmark

The Role & Department

This position contributes to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in early clinical development. This may include clinical trial implementation, and oversight of all aspects of clinical development working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables.

Responsibilities

Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds;
Work closely with the Medical Director and other Clinical Research Scientists, as needed;
Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan;
Participate in the development and review of study plans, and serve as a liaison to project teams and CROs;
Give medical input for country/site selection, feasibility assessment and engage in key opinion leader interaction;
Chip in to training of investigators, sites and CRO/CRA, as warranted;
Contribute to the development of clinical and regulatory documents and registration dossiers i.e., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions (briefing documents, IND, clinical dossiers) to support registration and commercialization of the compound(s) in collaboration with the Medical Director;
Participate in the development of case report forms and their completion guidelines, and provide scientific support for other key data management deliverables e.g. database lock activities;
Prepare charters, presentations and coordinate/participate in relevant committee meetings i.e., Dose Escalation, Data Monitoring and Safety Committees;
Lead the development of the medical data review plan, perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis;
Provide input for the development of abstracts/publications in coordination with Scientific Communications.

Requirements

PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline;
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 oral, written and interpersonal (communication) skills;
Ability to travel, as needed.

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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