Senior Clinical Research Scientist

Unclassified - Roseburg, OR

Full-time - Senior

Roseburg, OR

About the position

At Genmab, we are committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. As a Sr Clinical Research Scientist in the Medical department, you will play a crucial role in contributing to the implementation of the global development strategy. This includes leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds at various stages of clinical development. Your responsibilities will encompass clinical trial implementation and oversight of all aspects of clinical development, working closely with the Medical Director and other cross-functional teams to ensure high-quality and timely deliverables. In this role, you will be responsible for the development of the program strategy for assigned trials and compounds, participating in the creation of the clinical development plan (CDP). You will collaborate with the Medical Director to develop clinical and regulatory documents, including annual safety updates and registration dossiers. Additionally, you will participate in the development of case report forms (eCRFs) and provide scientific support for key data management deliverables. Your expertise will be essential in leading the development of the medical data review plan (MDRP), performing ongoing data reviews, and summarizing efficacy and safety data for interpretation and analysis. You will also contribute to country/site selection, feasibility assessments, and engage in interactions with key opinion leaders (KOLs). Your role will involve preparing charters and coordinating internal and external committee meetings, including presentation preparation for various committees. Furthermore, you will participate in the development and review of study plans and serve as a liaison to project teams and CROs, providing input for the development of publications in coordination with Scientific Communications. Training at Investigator meetings and CRO/CRA training will also be part of your responsibilities as warranted.

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 Sr. level Clinical Research Scientists as warranted.
• Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP).
• Collaborate with the Medical Director to develop clinical and regulatory documents, annual safety updates, and registration dossiers.
• Participate in the development of case report forms (eCRFs) and provide scientific support for key data management deliverables.
• 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.
• 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

• 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.

Benefits

• Competitive salary based on skills, qualifications, experience, and location.
• Eligibility for additional forms of compensation, such as bonuses.