Clinical Operations Director

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We are seeking an exceptional Clinical Operations Director to join our team at Genmab.

This is a unique opportunity to lead our Global Inspection Readiness function, driving excellence in clinical trial management and ensuring compliance with regulatory standards. As a seasoned professional, you will oversee the readiness of clinical trial procedures and documents for regulatory scrutiny, leveraging your expertise to minimize risks and ensure trials can withstand regulatory examination.

The role offers flexibility in location, with options in the United States, Denmark, or the Netherlands. You will be responsible for direct leadership of an international team of clinical inspection readiness managers, fostering collaboration with clinical research organizations (CROs), trial teams, and quality assurance experts.

About This Opportunity
  • $160,000 - $220,000 per year salary range
  • Leadership experience in managing clinical trials, focusing on quality assurance, process optimization, and regulatory compliance
  • Proven ability to transform strategic visions into actionable operational plans
  • Exceptional relationship-building skills, essential for fostering collaboration and driving proactive compliance activities across diverse teams and stakeholders
Your Responsibilities
  1. Direct an international team of clinical inspection readiness managers, ensuring strict adherence to Good Clinical Practice (GCP) and leading project management efforts
  2. Craft and execute comprehensive inspection readiness strategies on a global scale, maintaining close coordination with trial management and quality assurance teams
  3. Utilize key performance indicators (KPIs) to monitor and enhance clinical inspection readiness, aligning efforts with both organizational objectives and regulatory requirements
  4. Enhance inspection readiness processes by partnering with quality assurance to develop training, establish best practices, and spearhead process and system improvements based on audit and inspection feedback
  5. Drive risk management efforts by identifying and mitigating non-compliance risks across clinical trials, working alongside quality assurance for regular audits and evaluations
About Us

Genmab is a dynamic company dedicated to transforming the lives of patients through innovative cancer treatment. We offer a collaborative work environment, flexible locations, and opportunities for growth and development. If you're passionate about clinical operations and committed to delivering excellence, we encourage you to apply for this exciting opportunity.



  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job SummaryThe Clinical Operations Director will be responsible for overseeing the inspection readiness of clinical trials at Genmab. This role involves cultivating an international team committed to achieving superior inspection readiness, ensuring compliance with Good Clinical Practice (GCP) and other relevant standards.Key ResponsibilitiesDirect an...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    The Senior Director, Head of Programming role is a critical position within Genmab's Clinical Operations department. As a key member of the Development Operations Leadership Team, this individual will be responsible for defining the overall strategy and identifying development areas for the organization.As the Head of Programming, the employee will drive...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job SummaryWe are seeking a highly experienced Clinical Operations Director to lead our Programming Strategy team at Genmab. As a key member of our Development Operations Leadership Team, you will be responsible for driving the overall strategy and development areas of the organization.About the RoleIn this role, you will work closely with our HoF...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleAs the inaugural leader of Genmab’s clinical Inspection Readiness function, you will be instrumental in cultivating an international team committed to achieving superior inspection readiness across our clinical trials. Your mission will be to oversee the readiness of clinical trial procedures and documents for regulatory scrutiny, ensuring...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About GenmabGenmab is a biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. We believe in the importance of rigorous science and collaboration in driving our mission forward.Job SummaryWe are seeking an experienced Program Manager, Clinical Operations Director to lead our programming team in delivering...


  • Copenhagen, Copenhagen, Denmark MeetFrank Full time

    Associate Director, Global Clinical Trial ManagerAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionAt Genmab, we are seeking a seasoned leader to spearhead our clinical inspection readiness efforts. As the inaugural head of this function, you will be responsible for cultivating a high-performing international team dedicated to ensuring superior inspection readiness across our clinical trials.Key ResponsibilitiesTeam Leadership: Direct an...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionThe role of Clinical Data Management Director at Genmab is operationally responsible for overseeing External Data Quality Management activities related to effective planning and timely delivery of complete, high-quality, and reliable external data for clinical trials.The Director will provide strategic input to support Genmab clinical...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleThe Clinical Inspection Readiness Director will be responsible for cultivating an international team committed to achieving superior inspection readiness across our clinical trials. This strategic leadership role involves overseeing the readiness of clinical trial procedures and documents for regulatory scrutiny, ensuring compliance with Good...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    The Director, Team Lead, External Data Quality Management, Clinical Data Management at Genmab is responsible for overseeing External Data Quality Management activities. This includes effective planning and timely delivery of complete, high-quality, and reliable external data for clinical trials.The Director will provide oversight to ensure end-to-end...


  • Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full time

    About the RoleWe are seeking a skilled Clinical Program Lead to join our Global Clinical Development (GCD) organization at Ferring Pharmaceuticals A/S. As a key member of our team, you will play a central role in bridging the clinical parts of our matrix organization, driving clinical development programs, and ensuring alignment of execution strategies,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleAs Director of Programming Operations, you will be responsible for driving the overall strategy related to programming activities within Genmab. You will work closely with senior management and other departments to ensure that all teams and employees are working towards the same objectives.The ideal candidate will have a strong background in...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    The Director of Clinical Data Management at Genmab is responsible for overseeing the External Data Quality Management function, ensuring the timely delivery of high-quality external data for clinical trials.The Director will provide strategic input to support Genmab clinical development programs, ensuring external data management excellence. They will also...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Director, Team Leader, External Data Quality Management, Clinical Data ManagementThis leadership role oversees the management of external data quality activities for clinical trials at Genmab. The Director ensures timely delivery of high-quality and reliable data, while also providing strategic input to support clinical development programs.The role involves...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Clinical Compliance and Process Management plays a crucial role in ensuring our clinical trial processes meet regulatory standards at Lundbeck. As Clinical Operations Compliance Specialist, you will be responsible for developing and implementing a robust compliance framework that fosters a culture of adherence and accountability.Your new role will involve...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Transform the lives of patients with cancer and other serious diseases by joining Genmab's dynamic team as a Clinical Supply Operations Specialist.About UsGenmab is a pioneering biotechnology company committed to developing innovative antibody therapeutics. With over 20 years of experience, our team has invented next-generation antibody technology platforms,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Senior Clinical Data Manager Job DescriptionWe are seeking a skilled Senior Clinical Data Manager to lead our clinical data operations team.About the RoleThis is an exciting opportunity to join Genmab's dynamic and innovative company as a Senior Clinical Data Manager. As part of our global Clinical Operations team, you will play a key role in ensuring the...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a Senior Clinical Drug Supply Associate to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. This role will be responsible for executing tasks related to packaging, labeling, and distribution of clinical trial supplies.The ideal candidate will have experience in handling clinical drug supply,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Clinical Trial Operations ManagerAt Genmab, we're pushing the boundaries of cancer treatment. As a Clinical Trial Operations Manager, you'll play a crucial role in overseeing the filing of documents to ensure inspection readiness at trial level.Key Responsibilities:eTMF Management:Create and maintain Sponsor eTMF (trial, country, sites, EDL, upload of...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a seasoned Senior Clinical Trial Associate to join our team at Genmab. As a key member of our Clinical Operations group, you will be responsible for overseeing the filing of documents to ensure inspection readiness at trial level and supporting GCTM/CTM with key activities.Key Responsibilities:eTMF Management:Setup, maintain and...