Senior Clinical Research Scientist (Sr. CRS)

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Role
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 various stages of 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

• Contribute 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 various stages of clinical development (e.g. 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
• 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 (i.e., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions) 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
• Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
• Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., 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
• Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
• Mentor junior level Clinical Research Scientists as required

Requirements

• PhD, Pharm D, MS, Bachelor’s or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
• Minimum requirement: 6+ years of experience in clinical research with at least 3 or more years of drug development experience (preferably in oncology)
• Experience working in a project-oriented matrixed team environment
• Extensive knowledge and understanding of GCP
• Proven experience working in teams
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines
• Extensive knowledge and understanding of Clinical Research
• A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy
• Strong communication skills - both oral and written

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 comp