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! Key Responsibilities Support the planning, setup, and execution of global clinical trials, ensuring activities are delivered in accordance with timelines, quality standards, and regulatory requirements. Ensure trial oversight by maintaining accurate documentation and participating in inspection readiness activities. Collaborate with CROs and internal stakeholders to support site feasibility, selection, activation, and ongoing site management. Drive in the oversight of service providers, tracking deliverables, timelines, and quality to ensure alignment with study expectations. Support risk identification and mitigation activities, contributing to risk-based quality management throughout the trial lifecycle. Drive in managing protocol deviations and trial-level issues, ensuring proper documentation, follow-up, and escalation as needed. Support trial data review and performance tracking, contributing to reporting and identification of potential issues. Work collaboratively within a global, matrixed team environment, building strong relationships with internal teams, vendors, and investigators. Qualifications Bachelor's degree in life sciences or related field (Master's degree preferred). 5+ years of experience in clinical trial management within the pharmaceutical or biotechnology industry. Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle. Experience managing global, multi-center trials and working in a complex, matrixed organization. Project management and service provider oversight skills. Good communication, collaboration, and interpersonal skills. Oncology and/or therapeutic area-specific experience is highly desirable. For US based candidates, the proposed salary band for this position is as follows: $119,120.00 $178,680.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
07/02/2026
Full time
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! Key Responsibilities Support the planning, setup, and execution of global clinical trials, ensuring activities are delivered in accordance with timelines, quality standards, and regulatory requirements. Ensure trial oversight by maintaining accurate documentation and participating in inspection readiness activities. Collaborate with CROs and internal stakeholders to support site feasibility, selection, activation, and ongoing site management. Drive in the oversight of service providers, tracking deliverables, timelines, and quality to ensure alignment with study expectations. Support risk identification and mitigation activities, contributing to risk-based quality management throughout the trial lifecycle. Drive in managing protocol deviations and trial-level issues, ensuring proper documentation, follow-up, and escalation as needed. Support trial data review and performance tracking, contributing to reporting and identification of potential issues. Work collaboratively within a global, matrixed team environment, building strong relationships with internal teams, vendors, and investigators. Qualifications Bachelor's degree in life sciences or related field (Master's degree preferred). 5+ years of experience in clinical trial management within the pharmaceutical or biotechnology industry. Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle. Experience managing global, multi-center trials and working in a complex, matrixed organization. Project management and service provider oversight skills. Good communication, collaboration, and interpersonal skills. Oncology and/or therapeutic area-specific experience is highly desirable. For US based candidates, the proposed salary band for this position is as follows: $119,120.00 $178,680.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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! About the role The Senior Manager, Inspection Readiness plays a key role in supporting the Clinical Trial Operations organization by contributing to building clinical compliance and inspection readiness into trials and with service providers. This position is essential for maintaining high-quality clinical trial inspection readiness while ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. This individual will also lead process improvements. This is an individual contributor role at the Senior Manager level, with no direct people management responsibilities. Responsibilities Trial Inspection Readiness and Preparation Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance. Guide study teams to ensure trial inspection readiness by providing GCP and clinical compliance support - including risk mitigation and monitoring, GCP serious breaches or other non/reportable persistent non-compliance events, quality events - follow-up and closure, contributing to increased sponsor oversight. Drive continuous assessments of compound and/or trial inspection readiness by analysing key metrics to interpret and generate actionable insights. Lead the development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders. Collaborate closely with GCP QA and support the operational framework and inspection setup during sponsor and site/vendor GCP inspections. Develop and conduct lessons learned from inspection readiness, preparations and outcomes within Clinical Trial Operations. Quality Events Oversight Maintain oversight and drive compliance of Clinical Trial Delivery quality events and effectiveness checks. Completes trending of findings from audits, inspections and Quality Events as relevant for roles within Clinical Trial Operations and other key stakeholders. Clinical Compliance Provide support related to ICH-GCP, regulatory requirements (e.g. FDA, EMA, MHRA, PMDA, NMPA) and Genmab SOPs. Lead and contribute in functional and/or cross-functional business processes or system enhancement/innovative initiatives. Requirements Master's (MSc) degree in Life Sciences, Pharmacy, Medicine or a related discipline. Minimum of 8 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance role within the pharmaceutical or biotechnology industry. Strong understanding of clinical trial processes, ICH-GCP & regulations, and the clinical drug development lifecycle. Project management skills and knowledge of tools and processes. Experience mentoring and supporting the development of colleagues. Excellent written and verbal communication skills. Ability to proactively identify risks, develop mitigation strategies, and effectively resolve issues. Strong stakeholder management skills with the ability to collaborate effectively across functions working in a complex, global, and matrix organization. For NL based candidates, the proposed salary band for this position is as follows: EUR 64,000.00 - EUR 90,000.00 For DK based candidates, the proposed salary band for this position is as follows: DKK 687.880.00 - DKK 1.031.832.00 For US based candidates, the proposed salary band for this position is as follows: $130,560.00 $195,840.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
07/01/2026
Full time
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! About the role The Senior Manager, Inspection Readiness plays a key role in supporting the Clinical Trial Operations organization by contributing to building clinical compliance and inspection readiness into trials and with service providers. This position is essential for maintaining high-quality clinical trial inspection readiness while ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. This individual will also lead process improvements. This is an individual contributor role at the Senior Manager level, with no direct people management responsibilities. Responsibilities Trial Inspection Readiness and Preparation Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance. Guide study teams to ensure trial inspection readiness by providing GCP and clinical compliance support - including risk mitigation and monitoring, GCP serious breaches or other non/reportable persistent non-compliance events, quality events - follow-up and closure, contributing to increased sponsor oversight. Drive continuous assessments of compound and/or trial inspection readiness by analysing key metrics to interpret and generate actionable insights. Lead the development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders. Collaborate closely with GCP QA and support the operational framework and inspection setup during sponsor and site/vendor GCP inspections. Develop and conduct lessons learned from inspection readiness, preparations and outcomes within Clinical Trial Operations. Quality Events Oversight Maintain oversight and drive compliance of Clinical Trial Delivery quality events and effectiveness checks. Completes trending of findings from audits, inspections and Quality Events as relevant for roles within Clinical Trial Operations and other key stakeholders. Clinical Compliance Provide support related to ICH-GCP, regulatory requirements (e.g. FDA, EMA, MHRA, PMDA, NMPA) and Genmab SOPs. Lead and contribute in functional and/or cross-functional business processes or system enhancement/innovative initiatives. Requirements Master's (MSc) degree in Life Sciences, Pharmacy, Medicine or a related discipline. Minimum of 8 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance role within the pharmaceutical or biotechnology industry. Strong understanding of clinical trial processes, ICH-GCP & regulations, and the clinical drug development lifecycle. Project management skills and knowledge of tools and processes. Experience mentoring and supporting the development of colleagues. Excellent written and verbal communication skills. Ability to proactively identify risks, develop mitigation strategies, and effectively resolve issues. Strong stakeholder management skills with the ability to collaborate effectively across functions working in a complex, global, and matrix organization. For NL based candidates, the proposed salary band for this position is as follows: EUR 64,000.00 - EUR 90,000.00 For DK based candidates, the proposed salary band for this position is as follows: DKK 687.880.00 - DKK 1.031.832.00 For US based candidates, the proposed salary band for this position is as follows: $130,560.00 $195,840.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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! The Role: The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g. laboratories, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of the external clinical data integration processes as well as oversight of data quality from various external providers performing testing or data collection services on behalf of Genmab. The EDAL serves as the subject matter expert for all external data management activities performed for clinical trial teams. This role provides strategic data management expertise and is accountable for all end-to-end Data Management activities and deliverables pertaining to external data. The employee will provide oversight of external vendors and the data and/or data services they provide to Genmab. The External Data Lead will support the development and optimization of processes and tools to enable success of the Clinical Operations department. The employee will represent Data Management in Operational Committee's/fora with the partners and/or DM/stat vendors. The employee will support /train colleagues in and advise on handling of external data management related processes/issues and may act as a mentor. Moreover, the employee shall support the overall strategy and development of Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams. Responibilites: Lead external data acquisition across one or more studies/programs, ensuring high-quality, timely, analysis-ready data aligned with trial objectives. Influence protocol and amendment development by advising on external data collection design, integration feasibility, and alignment with CDASH/SDTM and EDC requirements. Lead planning and oversight of external data flow strategies and DTS across diverse data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration. Partner with cross-functional stakeholders to ensure external data acquisition supports operational and scientific goals. Develop and manage Trial Data Integrity Plans (TDIP) and Data Flow Create and maintain data transfer specifications (DTS) requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Ensure vendor data is transferred in standard data formats. Provide thorough review of external vendors budget and change order Act as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs). Mentor and guide junior External Data Acquisition Leads, providing direction on best practices, issue resolution, and development. Lead cross-functional initiatives including SOP development, process improvement, tools optimization, and external data standards governance. Partner with procurement/legal/vendor managers to review technical language in contracts and work orders, ensuring alignment with Genmab standards and systems. Promote portfolio-level consistency and scalability through training, knowledge sharing, and strategic planning support. Mentor and develop team members to ensure consistency of External Data Management practices. Ensure External Vendor deliverables are performed in compliance with protocol, ICH, GCP and SOPs Requirements: Bachelor's or Master's degree in a relevant technical area; Master's degree preferred. 10+ years of experience in external or clinical data management, with strong third-party vendor oversight and data acquisition experience. Experience working on Oncology trials/data Experience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM). Strong knowledge of diverse external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and ability to align acquisition strategies to clinical and analytical objectives. Experience managing projects, vendors, and process improvements in global environments. Proven performance in earlier role. For US based candidates, the proposed salary band for this position is as follows: $157,360.00 $236,040.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
07/01/2026
Full time
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! The Role: The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g. laboratories, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of the external clinical data integration processes as well as oversight of data quality from various external providers performing testing or data collection services on behalf of Genmab. The EDAL serves as the subject matter expert for all external data management activities performed for clinical trial teams. This role provides strategic data management expertise and is accountable for all end-to-end Data Management activities and deliverables pertaining to external data. The employee will provide oversight of external vendors and the data and/or data services they provide to Genmab. The External Data Lead will support the development and optimization of processes and tools to enable success of the Clinical Operations department. The employee will represent Data Management in Operational Committee's/fora with the partners and/or DM/stat vendors. The employee will support /train colleagues in and advise on handling of external data management related processes/issues and may act as a mentor. Moreover, the employee shall support the overall strategy and development of Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams. Responibilites: Lead external data acquisition across one or more studies/programs, ensuring high-quality, timely, analysis-ready data aligned with trial objectives. Influence protocol and amendment development by advising on external data collection design, integration feasibility, and alignment with CDASH/SDTM and EDC requirements. Lead planning and oversight of external data flow strategies and DTS across diverse data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration. Partner with cross-functional stakeholders to ensure external data acquisition supports operational and scientific goals. Develop and manage Trial Data Integrity Plans (TDIP) and Data Flow Create and maintain data transfer specifications (DTS) requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Ensure vendor data is transferred in standard data formats. Provide thorough review of external vendors budget and change order Act as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs). Mentor and guide junior External Data Acquisition Leads, providing direction on best practices, issue resolution, and development. Lead cross-functional initiatives including SOP development, process improvement, tools optimization, and external data standards governance. Partner with procurement/legal/vendor managers to review technical language in contracts and work orders, ensuring alignment with Genmab standards and systems. Promote portfolio-level consistency and scalability through training, knowledge sharing, and strategic planning support. Mentor and develop team members to ensure consistency of External Data Management practices. Ensure External Vendor deliverables are performed in compliance with protocol, ICH, GCP and SOPs Requirements: Bachelor's or Master's degree in a relevant technical area; Master's degree preferred. 10+ years of experience in external or clinical data management, with strong third-party vendor oversight and data acquisition experience. Experience working on Oncology trials/data Experience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM). Strong knowledge of diverse external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and ability to align acquisition strategies to clinical and analytical objectives. Experience managing projects, vendors, and process improvements in global environments. Proven performance in earlier role. For US based candidates, the proposed salary band for this position is as follows: $157,360.00 $236,040.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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! The Senior Programming Manager leads programming activities for complex or multiple trials, ensuring consistency and excellence across deliverables. This role contributes to enterprise-level standards, training, and capability building, and oversees programming in support of regulatory submissions. As a subject matter expert in CDISC standards, regulatory requirements, and/or systems/process innovation, the Senior Programming Manager shapes proposals for governance and supports strategic initiatives that advance programming practices globally. The Senior Programming Manager role: Provide hands-on leadership for a trial of high complexity or multiple trials Drive consistency across trials. Contribute to enterprise standards and/or training; act as CDISC/regulatory SME. Support major Standards/Systems/Process capability, shaping proposals for the governance board. May oversee all programming activities in support of regulatory submission. Act as SME and/or pillar owner in the capability-governance framework. Experience: Bachelor's or Master's degree in statistics, biostatistics, computer science, or a related field and/or 8+ years of relevant experience in pharmaceutical/biotech environments. Skilled SAS programmer with strong knowledge of CDISC SDTM/ADaM models, efficient coding practices, and contextual understanding of clinical data. Analytical, thorough, and proactive, with the ability to manage multiple tasks independently while maintaining high quality and accountability. Collaborative team player with excellent communication, planning, and knowledge-sharing abilities. Oncology submission experience preferred For US based candidates, the proposed salary band for this position is as follows: $128,080.00 $192,120.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
07/01/2026
Full time
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! The Senior Programming Manager leads programming activities for complex or multiple trials, ensuring consistency and excellence across deliverables. This role contributes to enterprise-level standards, training, and capability building, and oversees programming in support of regulatory submissions. As a subject matter expert in CDISC standards, regulatory requirements, and/or systems/process innovation, the Senior Programming Manager shapes proposals for governance and supports strategic initiatives that advance programming practices globally. The Senior Programming Manager role: Provide hands-on leadership for a trial of high complexity or multiple trials Drive consistency across trials. Contribute to enterprise standards and/or training; act as CDISC/regulatory SME. Support major Standards/Systems/Process capability, shaping proposals for the governance board. May oversee all programming activities in support of regulatory submission. Act as SME and/or pillar owner in the capability-governance framework. Experience: Bachelor's or Master's degree in statistics, biostatistics, computer science, or a related field and/or 8+ years of relevant experience in pharmaceutical/biotech environments. Skilled SAS programmer with strong knowledge of CDISC SDTM/ADaM models, efficient coding practices, and contextual understanding of clinical data. Analytical, thorough, and proactive, with the ability to manage multiple tasks independently while maintaining high quality and accountability. Collaborative team player with excellent communication, planning, and knowledge-sharing abilities. Oncology submission experience preferred For US based candidates, the proposed salary band for this position is as follows: $128,080.00 $192,120.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses 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 company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab 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 Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.