Job description
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
Job Description
Contribute to the scientific and medical expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various stages of clinical development. Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP). Author and review clinical and regulatory documents, annual safety updates, and registration dossiers (i.e. protocol ICF, IB, annual safety updates, study reports, briefing updates, IND, and 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. Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction. Participate in the development and review of study plans and serve as a liaison to project teams and CROs. Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted. Provide input for the development of publications in coordination with Scientific Communications. Domestic and international travel up to 20% of the time as is customary and necessary for the occupation.
Job Requirements
The qualified candidate must have at least a Doctor of Medicine or foreign equivalent degree in a medical, biological, pharmaceutical science or closely related field. The qualified candidate must have at least 2 years (24 months) of experience working in a clinical setting with oncology/hematology drug development. The qualified candidate must have at least 2 years (24 months) of experience with all the following: (a) Contributing to the development of the program strategy for assigned trials/compounds; (b) Participating in the development of the clinical development plan (CDP); (c) Leading clinical science activities from study start-up through database lock leading into CSR writing and submission; (d) Reviewing ongoing summary hematology/oncology data including safety, primary efficacy variables, and laboratory data; (e) Directing the planning and implementation of clinical programs to meet corporate and clinical research goals; (f) Facilitating CRO and site protocol trainings; and (g) Leading the response to protocol comments. All experience may be gained concurrently.
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.
At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.
Genmab US, Inc. is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website:
https://www.genmab.com/privacy/us-applicants-privacy-notice/
Scam alert
Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation. This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.
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