Genmab

Manager

• Manage and coordinate drug supply and provide IMP for clinical trials
• Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials
• Set-up English Master Label, manage label translation with our vendor and approval of label proofs/designs
• Manage set-up of distribution framework through service providers
• Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials
• Contribute to maintenance of SOPs and Work Instructions in the department
• Perform training of other team members
• Function as Subject Matter Expert within relevant areas
• Responsible for being compliant with Genmab’s quality system

Senior Clinical Drug Supply Manager

Director

• Ensure operational excellence of the HEOL team including alignment with corporate objectives/tactics, cross-functional partnership and external decision-maker engagements
• Provide guidance of medical insight reporting, analytics, and communication of actionable items to internal stakeholders as appropriate
• Ensure collaboration with Market Access to successfully meet corporate goals and objectives for access and reimbursement
• Provide oversight of training in collaboration with the Medical Affairs training team
• Facilitate professional development and manage performance of direct reports including providing constructive and timely performance feedback
• Directly observe and coach direct reports
• Ensure each HEOL has developed a medical/HEOR strategy for their key accounts and is building proactive, medical/HEOR relationships
• Participate actively as a member of the US Field Medical Affairs Leadership team in strategic planning, execution and reporting oversight of the HEOL Team
• Partner effectively with Market Access Leadership, both for the Payer and Corporate Accounts Teams, to ensure aligned execution of the value and decision-maker engagement strategies
• Serve as the Medical Affairs leader for internal and external executive engagements as it pertains to HEOL related business needs, insights, and strategic input
• Proactively partner with cross-functional leaders to forecast and plan headcount and capability needs for the HEOL team in alignment with evolving business strategies and organizational priorities
• Partner with CORE Leadership and US CORE Directors to share insights and needs for materials related to field engagement
• Cooperate with Field Medical Affairs leadership team to co-lead and manage change initiatives in the field to enable positive business outcomes
• Attract, hire, develop and retain a diverse and high-performing HEOL team
• Partner with Field Medical Affairs leadership to communicate HEOL team achievement updates to appropriate internal partners and levels of management
• Co-lead the creation and implementation of HEOL field collaborative strategies to ensure compliant partnership with other customer-facing teams across Genmab product life-cycles
• Lead various cross-functional initiatives/projects as requested
• Provide an optimal working environment by fostering the Genmab culture and values of our passion for innovation; we work as one team and respect each other; we are determined to be the best at what we do; and we work with integrity-we do the right thing
• Oversee direct report compliance with the Genmab Code of Conduct, guidelines and all policies
• Responsible for timely completion of administrative duties (ie: approval of timesheets, expense reports, evaluations, etc.)
• Attend medical/scientific meetings to represent US Field Medical Affairs/CORE and synthesize medical insight to enhance program strategies

Director, Health Evidence and Outcomes Liaison Team Lead

Account Manager

• Build and maintain strong professional relationships with key customers and stakeholders in private practice, medical group practices, hospitals/academic medical centers, office, and ancillary staff involved in the care of cancer patients
• Support Genmab’s Oncology portfolio in the U.S. marketplace
• Responsible for meeting or exceeding assigned sales goals for the territory by effectively positioning the benefits and use of Genmab’s products for appropriate patients
• Demonstrate effective time management by focusing efforts on engagements that drive brand value
• Develop and implement robust territory business plans centered on performance; meet or exceed territory productivity requirements
• Flex between virtual and in-person engagements and develop business plan considering account communication preferences
• Analyze key market data points and action insights into effective business planning
• Develop strong and long-term relationships with customers in all assigned accounts, challenging customers with value-based solutions
• Represent Genmab’s brands in a professional, compliant, ethical, and effective manner
• Maintain thorough understanding of disease states, Genmab’s brands and relevant competitor products and articulate value through all communication mediums
• Possess deep understanding of the reimbursement and fulfillment pathways for injectable medications
• Demonstrate highly effective territory management and superior selling competencies
• Creatively gain access to customers in the modern landscape
• Foster team effectiveness and shared goals by sharing knowledge, experience, and information
• Effectively manage territory resources and budget
• Comply with all laws, regulations and policies that govern the conduct of Genmab U.S. staff

Senior Oncology Account Manager

• Lead and develop a team of Oncology Account Managers in the Southeast region (FL, AL, GA, SC, NC and Puerto Rico)
• Develop and implement regional/national sales strategies and programs to meet/exceed sales goals
• Recruit, hire, train, evaluate, and develop sales team members
• Focus team on delivering customer-specific, value-based selling across digital and in-person channels
• Establish relationships with key customers and opinion leaders and collaborate with alliance partners
• Evaluate business environment and practice models to build internal and external partnerships
• Analyze region/division business and build short- and long-term business plans
• Ensure compliance with corporate policies, regulatory and legal standards, and financial/budgetary guidelines
• Communicate market intelligence to brand teams and management and participate in meetings regularly

Regional Business Director – Hematology

• Act as a biostatistician supporting the clinical development of compounds as compound lead and/or trial responsible statistician
• Act as lead and main point of contact related to Statistics for designated compound/indication
• Follow scientific and technical progress within the field of biostatistics and advise new methodologies
• Engage with regulatory authorities on compound/indication and trial level discussions
• Ensure consistency of statistical methods and data handling across trials
• Provide scientific advice to the CDT including design of trials, analyses and advanced methodologies
• Represent the CDT/the company at regulatory meetings, KOL meetings, and partner meetings
• Drive design and synopsis development and ensure transparent communication to stakeholders
• Ensure availability of integrated databases and planning/conduct of integrated analyses
• Support development and communication of presentations, posters, and articles
• Coordinate data transfers with partners and participate in vendor oversight and CTT activities
• Review and provide input to protocol and amendment development, SAPs, CSRs, and other trial documentation
• Perform exploratory, ad hoc analyses, modelling; review randomization plans and perform UAT of IRT systems
• Support timely delivery of statistical deliverables and regulatory submission/filing activities

Senior Manager, Biostatistics

Medical Director

Support development of individual trial protocols in view of clinical development plan
Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards
Drive and monitor quality of all clinical documents (e.g., protocols, study reports, Investigators’ Brochures, clinical components of regulatory submissions, safety documents)
Support/lead creation/review of clinical components of key documents, 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] for registration, market access, and commercialization of the compound(s)
Support oversight of the safety of the drug, including the safety aspects of patients in clinical studies and signal detection
Support the development of other relevant medical deliverables: concept sheets, briefing books, and label and marketing application dossier, clinical development plans
Contribute to the development of the program strategy for assigned trials/compounds
Support creation, integration, and execution of overall medical strategy of assigned clinical development programs
Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide input to key external presentations
Support interaction with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel methods of development
Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge

Associate Medical Director

Operations

• Lead delivery of compliant, submission-ready labeling documents and packaging mockups/artwork for US and EU Centralized Procedure (CP)
• Oversee external vendors and local regulatory consultants delivering timely, compliant labeling for local markets and product maintenance
• Partner with Regulatory, Commercial, Supply Chain, Quality and other stakeholders to lead or oversee mockup/artwork development and submission/launch readiness
• Support development and continuous improvement of global end-to-end labeling processes, tools, systems and infrastructure
• Provide guidance on global labeling requirements and evolving industry standards
• Develop and maintain processes to support RIM document control, lifecycle management and tracking for labeling documents
• Manage vendor delivery of EU CP translations, U.S. Structured Product Labeling (SPL), and other market-specific submission deliverables
• Lead or oversee development of market-specific labeling processes (WIs/SOPs, templates) and manage vendor relationships, contracts, training and budgets
• Contribute labeling input to PSURs, Annual Reports, and other periodic regulatory reports
• Support regulatory intelligence deliverables related to global labeling activities and lead projects like electronic labeling
• Ensure all activities comply with internal SOPs, global regulatory requirements, and GxP standards