Genmab

Medical Director

• Lead the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP).
• Lead creation and review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers.
• Oversee early-stage programs and develop clinical programs including component studies.
• Oversee safety of the drug, including the safety aspects of patients in clinical studies and signal detection with support of the Safety physician.
• Create, integrate, and execute overall medical strategies of assigned clinical development programs.
• Contribute to publication and clinical communication strategy in coordination with Scientific Communications.
• Interact with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines.

Compliance

• Supporting and optimizing core Regulatory Operations systems, including Veeva Vault RIM, Toolbox, Acumen Authoring Tool, and associated health authority portals
• Ensuring effective system governance, data integrity, compliance, and end-user support
• Partnering cross-functionally to enable efficient regulatory submissions, registrations, and lifecycle management activities across global markets
• Creating and/or participating in deviations, CAPAs, Change Controls, and projects related to Regulatory Operations and Veeva RIM Vault
• Partnering with Digital Enablement team for configuration testing, UAT creation and developments, and deployment into sandboxes and PROD environments
• Developing reports for stakeholders, performing impact assessments on reports due to system enhancements, and executing updates as necessary
• Attending Core team meetings and prioritizing changes from upcoming Veeva releases and enhancements
• Processing and triaging access request tickets to the RIM Vault, ticket requests for changes and support, and working on backlog change log items
• Processing requests and creating Master Data in the RIM Vault while meeting data governance criteria
• Monitoring Application Join creation and ensure eCTD data is meeting standardization and compliance requirements
• Providing ad hoc training and hands-on support for end users
• Supporting SOP and WI authoring, reviewing and approver as needed
• Coordinating updates and creations of eLearnings
• Monitoring and responding to inquiries to RIMSupport inbox and general end user technical and process support
• Assisting with periodic internal user review, periodic external user review, and annual audit trail
• Supporting RIM Registrations activities and verifications activities
• Providing authoring support, specifically Acumen templates which includes performing quality checks and converting documents to be compliant
• Using Toolbox to assist with PDF submission-readiness

Senior Manager, Global Regulatory Operations – Regulatory Systems

Data Engineer

• Design, build, and maintain scalable and reliable data pipelines
• Improve performance, efficiency, and reliability across platforms
• Develop and maintain data marts and dashboards
• Implement automation and CI/CD practices
• Collaborate with cross-functional teams to meet business needs

EU Commercial Data Engineer

Financial Planning and Analysis

• Take end‑to‑end accountability for assigned A2R process areas
• Apply strong accounting judgment to ensure SAP solutions enable accurate financial reporting and decision‑making
• Proactively identify risks, dependencies, and improvement opportunities
• Drive simplicity by promoting standard, scalable SAP solutions
• Ensure A2R processes and SAP configurations comply with US GAAP, IFRS, internal controls, and audit requirements

Manager, ERP Finance – Account to Report

Director

• Lead or co-lead one or more complex clinical trial(s) in a therapeutic area for one or more compounds
• Works closely with Medical Director and Medical Program Lead (as warranted)
• Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
• Authors components with Medical Director and reviewer of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s)
• Contributes 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 (ie, 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
• Perform training at Investigator meetings, CRO/CRA training, SIVs as warranted
• Provide mentoring to junior level Clinical Research Scientists

Associate Director, CRS

• Provide strategic and operational regulatory CMC expertise across global development projects
• Develop and execute global regulatory CMC strategies for biological products
• Collaborate with cross-functional colleagues to optimize product development
• Plan and prepare CMC documentation for clinical applications

Associate Director, Global Regulatory Affairs, CMC

• Manage all aspects of state government relations within your assigned region, including through the following: hiring and supervising additional Government Affairs Directors (GADs) within your region as we expand our engagement footprint; hiring and supervising local lobbying counsel; and managing relationships with state-level patient advocacy and industry groups.
• Work collaboratively with USGAP and Commercial Operations colleagues, including Market Access, Customer Experience & Insights, Legal, Finance, Compliance, Sales, Marketing and others to identify, understand, develop and execute strategies to advance legislative and regulatory policies that benefit Genmab and the patients we aspire to serve.
• Monitor and track all relevant state legislative, regulatory, and public policy issues that may impact the patients we aspire to serve and Genmab’s U.S. operations. Develop background and communications materials to communicate such developments to internal and external audiences, where appropriate.
• Develop, implement, and execute lobbying and/or stakeholder-led campaigns that utilize the cross-functional expertise of Genmab USGAP and Commercial Operations.
• Embrace diversity of thought to understand the needs of, and develop strong relationships with, key internal business leaders, as well as external policymakers and other key stakeholders.
• Location-specific Genmab facility site-engagement, including employee programming, training interaction, and political action committee (PAC) recruitment, retention, and administration.
• Other duties or tasks as assigned.

Regional Director, State Government Affairs – Northeast

Data Scientist

• Operationally responsible for the planning, start-up, conduct and closure of clinical trials
• Provide oversight of the DM CRO and ensure performance against key indicators
• Support/training colleagues in handling data management related processes/issues and mentoring
• Participate in and drive implementation of lessons learned and new procedures to ensure high standards/improvement
• Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP
• Perform vendor oversight related to key deliverables
• Give input to the clinical development plans through the Development Operations representatives
• Support vendor qualification in terms of Data management, ePRO and IRT related activities