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 Director, Strategic Clinical Vendor Oversight and Relationship Lead is responsible for advancing and operationalizing Genmab's clinical outsourcing and vendor governance model across the development portfolio. In close partnership with the Head of Function, this role drives portfolio level CRO/clinical vendor performance management across all Clinical Trial Delivery, operating model refinement, and process innovation initiatives that enhance scalability, predictability, and quality of trial delivery. The position provides portfolio-wide visibility into vendor performance, leads cross-functional improvement programs, and ensures outsourcing practices evolve in alignment with Genmab's expanding Phase II/III pipeline. Responsibilities Operational Oversight Provide portfolio-level oversight of outsourced Phase I-III clinical trials, identifying systemic performance trends and execution risks across programs. Ensure vendor delivery aligns with strategic portfolio timelines, budget expectations, and quality standards. Lead resolution of complex or high-impact operational issues, serving as senior escalation point within established governance pathways Drive consistent application of oversight standards and performance expectations across study teams. Vendor Management Lead operational performance oversight of assigned clinical vendor(s), ensuring effective implementation of established governance frameworks and partnership models. Represent the function in Portfolio Operational Committee meetings and contribute to executive-level Steering Committee discussions in collaboration with the Head of Function as necessitated. Oversee performance analytics and trend reporting to enable proactive risk management and continuous improvement. Partner with Procurement to strengthen performance-based oversight and cost transparency. Process Optimization Lead department initiatives to refine and scale the outsourcing operating model in alignment with portfolio growth Identify systemic inefficiencies across trial start-up, execution, and closeout and implement standardized best practices to reduce variability. Drive development and adoption of governance playbooks, oversight dashboards, and performance metrics. Partner with Digital and innovation initiatives to modernize vendor oversight through data-driven tools and automation. Team support and Collaboration Serve as advisor and escalation resource to Development Operational Program Leaders, Global Trial Leaders, Clinical Trial Managers, and cross functional leaders on vendor oversight strategy and execution. Establish training frameworks and capability-building initiatives to elevate outsourcing and governance competencies across the organization. Foster a culture of accountability, partnership, and continuous improvement. Cross-functional Partnership Partner with key stakeholders within Clinical Trial Delivery, Clinical Strategy, Regulatory Affairs, Quality, Finance, and Procurement to ensure outsourcing practices support broader development objectives Provide strategic insight into vendor capacity, performance risks, and execution readiness to inform portfolio planning. Strengthen collaboration with vendors to promote transparency, proactive issue management, and long-term partnership effectiveness. Compliance and Governance Ensure outsourced trial activities align with ICH-GCP, global regulatory requirements, and Genmab quality systems Oversee inspection-readiness for vendor-managed activities and support audit preparedness across programs. Monitor industry and regulatory trends and recommend enhancements to governance practices accordingly. Qualifications Education Bachelor's degree required; advanced degree preferred. Experience 8-10+ years of experience in clinical operations, vendor oversight, or outsourcing management within biotech/pharma. Experience working in clinical trial management and execution Familiarity with portfolio-level operational standards Solid understanding of ICH-GCP and global regulatory requirements. For US based candidates, the proposed salary band for this position is as follows: $193,280.00 $289,920.00 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.
08/17/2026
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 Director, Strategic Clinical Vendor Oversight and Relationship Lead is responsible for advancing and operationalizing Genmab's clinical outsourcing and vendor governance model across the development portfolio. In close partnership with the Head of Function, this role drives portfolio level CRO/clinical vendor performance management across all Clinical Trial Delivery, operating model refinement, and process innovation initiatives that enhance scalability, predictability, and quality of trial delivery. The position provides portfolio-wide visibility into vendor performance, leads cross-functional improvement programs, and ensures outsourcing practices evolve in alignment with Genmab's expanding Phase II/III pipeline. Responsibilities Operational Oversight Provide portfolio-level oversight of outsourced Phase I-III clinical trials, identifying systemic performance trends and execution risks across programs. Ensure vendor delivery aligns with strategic portfolio timelines, budget expectations, and quality standards. Lead resolution of complex or high-impact operational issues, serving as senior escalation point within established governance pathways Drive consistent application of oversight standards and performance expectations across study teams. Vendor Management Lead operational performance oversight of assigned clinical vendor(s), ensuring effective implementation of established governance frameworks and partnership models. Represent the function in Portfolio Operational Committee meetings and contribute to executive-level Steering Committee discussions in collaboration with the Head of Function as necessitated. Oversee performance analytics and trend reporting to enable proactive risk management and continuous improvement. Partner with Procurement to strengthen performance-based oversight and cost transparency. Process Optimization Lead department initiatives to refine and scale the outsourcing operating model in alignment with portfolio growth Identify systemic inefficiencies across trial start-up, execution, and closeout and implement standardized best practices to reduce variability. Drive development and adoption of governance playbooks, oversight dashboards, and performance metrics. Partner with Digital and innovation initiatives to modernize vendor oversight through data-driven tools and automation. Team support and Collaboration Serve as advisor and escalation resource to Development Operational Program Leaders, Global Trial Leaders, Clinical Trial Managers, and cross functional leaders on vendor oversight strategy and execution. Establish training frameworks and capability-building initiatives to elevate outsourcing and governance competencies across the organization. Foster a culture of accountability, partnership, and continuous improvement. Cross-functional Partnership Partner with key stakeholders within Clinical Trial Delivery, Clinical Strategy, Regulatory Affairs, Quality, Finance, and Procurement to ensure outsourcing practices support broader development objectives Provide strategic insight into vendor capacity, performance risks, and execution readiness to inform portfolio planning. Strengthen collaboration with vendors to promote transparency, proactive issue management, and long-term partnership effectiveness. Compliance and Governance Ensure outsourced trial activities align with ICH-GCP, global regulatory requirements, and Genmab quality systems Oversee inspection-readiness for vendor-managed activities and support audit preparedness across programs. Monitor industry and regulatory trends and recommend enhancements to governance practices accordingly. Qualifications Education Bachelor's degree required; advanced degree preferred. Experience 8-10+ years of experience in clinical operations, vendor oversight, or outsourcing management within biotech/pharma. Experience working in clinical trial management and execution Familiarity with portfolio-level operational standards Solid understanding of ICH-GCP and global regulatory requirements. For US based candidates, the proposed salary band for this position is as follows: $193,280.00 $289,920.00 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! Position Summary: Director, Medical Information is responsible for overseeing the delivery of high-quality medical information in a designated therapy area. This role involves providing strategic leadership, ensuring compliance with regulatory guidelines, and managing a team of medical information professionals, both internal and external. Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. Domestic and international travel will be required: 2-3 domestic/international congresses and company meetings. Responsibilities will include, but are not limited to, the following: Define and execute the Medical Information strategy for the designated therapy area by exemplifying partnership across Medical Affairs, Commercial, Regulatory Affairs, and other cross-functional colleagues Lead a team of Medical Information professionals to deliver planning for new product launches, line extensions, and key data releases, as applicable, for the designated therapy area Ensure the development and maintenance of high-quality, scientifically accurate and balanced medical and scientific information, including Standard/Custom Response Letters and payor dossiers in the designated therapy area Leverage scientific mindset and creativity to deliver best-in-class Field Medical resources Direct the Medical Information Call Center in responding to medical information inquiries from healthcare professionals, patients and payors to deliver accurate and timely responses for complex inquiries in the designated therapy area Provide medical review of promotional and medical materials to ensure content is accurate and medically appropriate Drive innovation in Medical Information delivery through digital engagement platforms, AI-enabled solutions, and advanced analytics Lead submission(s) of compendia and guideline listings for Genmab products in the designated therapy area Proactively analyze and distribute actionable insights and metrics to inform medical strategy Represent Medical Information function at interdisciplinary meetings, congresses and vendor discussions Serve as a preceptor to fellows/students and provide guidance to other members of the Medical Information team Manage agency partnerships and associated budgets Experience & Skills: Scientific or medical Degree (MD, PharmD, or PhD) required Prior experience with product launches, especially in US Prior experience in Oncology/Hematology preferred 10+ years of relevant experience (e.g. pharmaceutical industry-based medical information, medical writing, medical/promotional review, medical communications) Prior team leadership experience required Experience across multiple aspects of strategy, planning, and execution within area (publication, medical review etc.) during all phases of drug development and commercialization process Experience working with relevant laws, regulations, guidelines, and practices related to medical information Proven performance in earlier role/comparable role Ability to lead initiatives and work with team cross-functionally Possesses excellent communication skills, both oral and written Understanding and knowledge of FDA/Regulatory guidance on appropriate scientific exchange practices Demonstrated ability to build alignment, negotiate and collaborate Strong leadership and organization skills with a solutions orientated approach driving optimal business results in a complex matrix environment Must be a strong team player and be willing to work in a high-paced environment where individual initiative and accountability to the team are required Demonstrates flexibility in response to changing needs and competing demands For US based candidates, the proposed salary band for this position is as follows: $195,200.00 $292,800.00 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 Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process 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.
08/16/2026
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! Position Summary: Director, Medical Information is responsible for overseeing the delivery of high-quality medical information in a designated therapy area. This role involves providing strategic leadership, ensuring compliance with regulatory guidelines, and managing a team of medical information professionals, both internal and external. Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. Domestic and international travel will be required: 2-3 domestic/international congresses and company meetings. Responsibilities will include, but are not limited to, the following: Define and execute the Medical Information strategy for the designated therapy area by exemplifying partnership across Medical Affairs, Commercial, Regulatory Affairs, and other cross-functional colleagues Lead a team of Medical Information professionals to deliver planning for new product launches, line extensions, and key data releases, as applicable, for the designated therapy area Ensure the development and maintenance of high-quality, scientifically accurate and balanced medical and scientific information, including Standard/Custom Response Letters and payor dossiers in the designated therapy area Leverage scientific mindset and creativity to deliver best-in-class Field Medical resources Direct the Medical Information Call Center in responding to medical information inquiries from healthcare professionals, patients and payors to deliver accurate and timely responses for complex inquiries in the designated therapy area Provide medical review of promotional and medical materials to ensure content is accurate and medically appropriate Drive innovation in Medical Information delivery through digital engagement platforms, AI-enabled solutions, and advanced analytics Lead submission(s) of compendia and guideline listings for Genmab products in the designated therapy area Proactively analyze and distribute actionable insights and metrics to inform medical strategy Represent Medical Information function at interdisciplinary meetings, congresses and vendor discussions Serve as a preceptor to fellows/students and provide guidance to other members of the Medical Information team Manage agency partnerships and associated budgets Experience & Skills: Scientific or medical Degree (MD, PharmD, or PhD) required Prior experience with product launches, especially in US Prior experience in Oncology/Hematology preferred 10+ years of relevant experience (e.g. pharmaceutical industry-based medical information, medical writing, medical/promotional review, medical communications) Prior team leadership experience required Experience across multiple aspects of strategy, planning, and execution within area (publication, medical review etc.) during all phases of drug development and commercialization process Experience working with relevant laws, regulations, guidelines, and practices related to medical information Proven performance in earlier role/comparable role Ability to lead initiatives and work with team cross-functionally Possesses excellent communication skills, both oral and written Understanding and knowledge of FDA/Regulatory guidance on appropriate scientific exchange practices Demonstrated ability to build alignment, negotiate and collaborate Strong leadership and organization skills with a solutions orientated approach driving optimal business results in a complex matrix environment Must be a strong team player and be willing to work in a high-paced environment where individual initiative and accountability to the team are required Demonstrates flexibility in response to changing needs and competing demands For US based candidates, the proposed salary band for this position is as follows: $195,200.00 $292,800.00 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 Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process 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 Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Director contributes to clinical development strategies and plans. Responsibilities: Compound/Indication Level 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 in drug development and advise of new methodologies that may support innovation and improve efficiencies Engage with regulatory authorities on compound/indication level discussions Acts as a role model Ensures consistency of statistical methods and data handling across trials Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor Supports compound responsible programmer in developing an integrated database specification CDT member: Responsible for giving statistical input to overall strategy and the synopsis development in the CDT Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable Drive design and synopsis development together with relevant stakeholders Ensure transparent communication to relevant stakeholders from the CDT Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles Trial Level Represent Genmab during meetings/congresses and courses and perform professional networking Engage with regulatory authorities on trial level discussions Arranges/attends lessons learned to share learnings Represents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable Ensures state of the art statistical work which includes but is not limited to: Applying adequate methods for which a solid scientific foundation exists Ensure proper documentation of work done Keep oversight and QC essential documents/data provided by vendors Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP CTT member: Participate and represent Biostatistics Review and provide input to protocol and amendment development Perform vendor oversight according to applicable SOPs Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc. Review assay validation reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT of Randomization part of the IRT system as applicable Ensure procedures for blinding are in place as applicable Support timely delivery of statistical deliverables Responsible for planning and conducting trial result meetings Review and approve the CSR Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety: Participate in definition, review, and approval of data packages for Data Monitoring Committees Review and approve any amendments, corrections, and updates of data packages CRO selection and collaboration Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs) Attend operational and steering committee meetings, as applicable Support regulatory submission/filing activities Experience: Master's or PhD in a statistical discipline 12+ years of experience in relevant area preferred, or demonstrated capability Experience in statistical analysis, modelling and simulation and adaptive trial designs Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics Experience with the relevant regulatory requirements for biostatistics processes and SOPs Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions Experience directing multiple complex projects/studies in a technical capacity Experience leading and mentoring teams Proven performance in earlier role/comparable role For US based candidates, the proposed salary band for this position is as follows: $203,440.00 $305,160.00 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 Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process 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.
08/16/2026
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 Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Director contributes to clinical development strategies and plans. Responsibilities: Compound/Indication Level 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 in drug development and advise of new methodologies that may support innovation and improve efficiencies Engage with regulatory authorities on compound/indication level discussions Acts as a role model Ensures consistency of statistical methods and data handling across trials Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor Supports compound responsible programmer in developing an integrated database specification CDT member: Responsible for giving statistical input to overall strategy and the synopsis development in the CDT Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable Drive design and synopsis development together with relevant stakeholders Ensure transparent communication to relevant stakeholders from the CDT Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles Trial Level Represent Genmab during meetings/congresses and courses and perform professional networking Engage with regulatory authorities on trial level discussions Arranges/attends lessons learned to share learnings Represents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable Ensures state of the art statistical work which includes but is not limited to: Applying adequate methods for which a solid scientific foundation exists Ensure proper documentation of work done Keep oversight and QC essential documents/data provided by vendors Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP CTT member: Participate and represent Biostatistics Review and provide input to protocol and amendment development Perform vendor oversight according to applicable SOPs Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc. Review assay validation reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT of Randomization part of the IRT system as applicable Ensure procedures for blinding are in place as applicable Support timely delivery of statistical deliverables Responsible for planning and conducting trial result meetings Review and approve the CSR Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety: Participate in definition, review, and approval of data packages for Data Monitoring Committees Review and approve any amendments, corrections, and updates of data packages CRO selection and collaboration Perform vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Statistics and define/specify scope of work for functional tasks Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs) Attend operational and steering committee meetings, as applicable Support regulatory submission/filing activities Experience: Master's or PhD in a statistical discipline 12+ years of experience in relevant area preferred, or demonstrated capability Experience in statistical analysis, modelling and simulation and adaptive trial designs Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics Experience with the relevant regulatory requirements for biostatistics processes and SOPs Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions Experience directing multiple complex projects/studies in a technical capacity Experience leading and mentoring teams Proven performance in earlier role/comparable role For US based candidates, the proposed salary band for this position is as follows: $203,440.00 $305,160.00 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 Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process 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.