Senior Clinical Research Scientist

US001 Genmab US, Inc. - Princeton, NJ

Full-time - Senior

Princeton, NJ

About the position

As a Sr Clinical Research Scientist at Genmab, you will play a pivotal role in the Medical department, contributing to the implementation of the global development strategy. Your primary responsibility will be to lead or co-lead one or more clinical trials in a therapeutic area for one or more compounds that are in various stages of clinical development. This role encompasses 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. You will be instrumental in shaping the clinical development plan (CDP) and will collaborate with the Medical Director to develop essential clinical and regulatory documents, including protocols, informed consent forms (ICF), investigator brochures (IB), annual safety updates, and registration dossiers to support the registration and commercialization of the compounds. In addition to document development, you will participate in the creation of electronic case report forms (eCRFs) and provide scientific support for key data management deliverables, including database lock activities. You will lead the development of the medical data review plan (MDRP), perform ongoing data reviews, and summarize efficacy and safety data for interpretation and analysis. Your role will also involve contributing medical input for country and site selection, feasibility assessments, and engaging in interactions with key opinion leaders (KOLs). You will prepare charters and coordinate internal and external committee meetings, including presentation preparation for various committees such as the Dose Escalation Committee, Data Monitoring Committee (DMC), Steering Committee, and Safety Committees. Furthermore, you will participate in the development and review of study plans, serving as a liaison to project teams and contract research organizations (CROs). Your contributions will extend to the development of publications in coordination with Scientific Communications, and you may also be involved in training at Investigator meetings, CRO/CRA training, and Site Initiation Visits (SIVs) 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) and perform ongoing data review.
• Summarize efficacy and safety data for interpretation and analysis.
• Contribute medical input for country/site selection and 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, and 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.