Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role The CMC area of Genmab is growing and the Stability and Submission Support team is looking for an experienced CMC Writer to join us in Copenhagen. The CMC Writer specialist role is responsible for the authoring and coordinating activities needed to complete the Module 3 documents for IND/CTAs, amendments, HA response rounds, and BLA/MAAs. This CMC Writer role requires solid experience as a CMC writer, preferably with several IND ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role The Quality Assurance team at Genmab is growing. We are looking for a new colleague in an exciting role as Senior Manager to be a key player in the Commercial & Lifecycle QA GMP team. Genmab will launch a commercial product in 2023 and initiate early access programs for pre-commercial products. Genmab is preparing to submit a BLA and become a US Marketing Authorization Holder. In addition, Genmab has an exciting development ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role The Statistical Manager supports the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence for Clinical Research & Development and Medical Affairs programs with minimal supervision. This position supports statistical aspects of business-critical and/or regulatory commitments, provides input to program plans with limited supervision, and represents the Clinical ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role Genmab is hiring a Senior Manager or Associate Director, Clinical Programming reporting to the Princeton, NJ, US; Copenhagen, Denmark; or Utrecht, The Netherlands offices. The Senior Programming Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, performs sponsor oversight of relevant programming activities on the Biometrics vendor, and ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role Genmab is looking for a motivated Clinical Start-Up Lead to join the Global Clinical Operations team. The position can be based at our offices in Copenhagen, Denmark or Princeton, NJ USA. Global Clinical Operations is part of the Clinical Development department which is responsible for managing clinical cancer trials from early First-in-Human (FIH) studies to late-stage trials. As Start-Up Lead, you will be responsible for ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role Genmab is modernizing the corporate IT function globally to better serve the business and support company growth. Genmab is aiming to become a fully integrated global biotech company, operating in an efficient and compliant manner by providing IT solutions and services that enhance productivity and innovation. To support this strategy going forward, we are looking for a Director to lead our Technical Architecture and Design Team ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role Genmab is looking for a (senior) System Change & Release Manager to help us maintain, develop, and innovate our global electronic document management system (EDMS) – GenDocs, covering document management in the clinical, regulatory, CMC, Quality Assurance areas in Genmab. GenDocs is a global GxP IT system based on the Veeva Vault cloud platform, and it supports our dynamic and expanding R&D organization. R&D Business Systems ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role The CMC area of Genmab is growing and looking for a Subject Matter Expert (SME) – Upstream processing (USP) to join the CMC, Late Stage Manufacturing Development (LSMD) Team. As the USP SME, you will be part of a highly dedicated and specialized CMC team leading the late stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA). The SME will work across project teams to ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role The CMC area of Genmab is growing and looking for a Subject Matter Expert (SME) – Downstream processing CMC Specialist (DSP) to join the CMC, Late Stage Manufacturing Development (LSMD) Team. As the DSP SME, you will be part of a highly dedicated and specialized CMC team leading the late stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA). The SME will work across ...

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. The Role The CMC area of Genmab is growing and looking for an Analytical CMC Subject Matter Expert (SME) to join the CMC Late Stage Manufacturing Development (LSMD) Team. As the Analytical Subject Matter Expert (SME), you will be part of a highly dedicated and specialized CMC team leading the late stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA). The Analytical SME will ...