Manager of Clinical Drug Distribution

15 hours ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Job Summary

We're looking for a skilled Clinical Drug Supply Manager to join our team in Copenhagen, Denmark or Princeton, New Jersey.

This role involves managing clinical trial supplies, collaborating with CMOs, and ensuring compliance with quality standards.

About the Team

  • You'll be part of a highly competent team focused on packaging and labeling of supplies for clinical trials.
  • You'll work closely with the Global Clinical Drug Supply Planning team and our CMOs.

Responsibilities

  1. Coordinate drug supply and provide Investigational Medicinal Products (IMPs) for clinical trials, Investigator-Sponsored Trials (IST), and Pre-Approval Access (PAA) programs.
  2. Establish English Master Labels, oversee label translations, and approve label designs without vendor involvement.
  3. Set up distribution frameworks through service providers.
  4. Determine necessary drug supply activities at Contract Manufacturing Organizations (CMOs).
  5. Collaborate on Standard Operating Procedures (SOPs) and Work Instructions in the department.
  6. Train colleagues on relevant topics.
  7. Serve as a subject matter expert within specific areas.
  8. Maintain Genmab's quality system compliance.

What We're Looking For

  • A minimum of three years of experience in clinical drug supply management, including setup and management of label text and ancillaries.
  • Effective stakeholder management skills, both internal and external.
  • Experience working with CMOs for clinical trial supplies.
  • Training in Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP) is required.
  • Previous experience working with IST and PAA from a sponsor perspective would be advantageous.
  • Exceptional communication skills in English, both spoken and written.


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job OpportunityWe're seeking a seasoned Clinical Drug Supply Manager to join our team in Copenhagen, Denmark or Princeton, New Jersey.This position requires a strong background in cGMP and a focus on delivering high-quality results.About the JobManage the coordination of drug supply and provide IMPs for clinical trials, IST, and PAA programs.Develop and...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionWe are seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ.The ideal candidate will have extensive knowledge of cGMP and a focus on the level of quality in work performed. They will manage outsourcing of packaging, labeling, and distribution of clinical...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...


  • Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    Lundbeck A/S, H is a Danish pharmaceutical company that develops innovative treatments for brain disorders. As a Principal Investigator, you will lead the Department of Drug Metabolism within the Non-Clinical Safety Research division.Your primary responsibilities will involve evaluating the drug-drug interaction risk of Lundbeck development compounds,...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    We are looking for a seasoned Clinical Trial Program Manager to oversee the planning, execution, and delivery of our clinical trials. As a key member of our team, you will work closely with cross-functional teams to develop and implement trial strategies, manage trial timelines and budgets, and ensure compliance with regulatory requirements.About the JobThis...


  • Copenhagen, Copenhagen, Denmark Philips Iberica SAU Full time

    Job TitleClinical Marketing ManagerJob DescriptionAs a Clinical Decision Support Specialist you will support the key account management in serving our customers in the Nordic countries - both in the clinical and commercial area.Your role is:Establishing and maintaining relationships with key opinion leaders in the field of Sleep and Respiratory Care with the...


  • Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    Lundbeck A/S, H is a leading pharmaceutical company that focuses on developing innovative treatments for brain disorders. As a Principal Scientist, you will be part of the Department of Drug Metabolism within the Non-Clinical Safety Research division.Your main responsibilities will include evaluating the drug-drug interaction risk of Lundbeck development...


  • Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time

    Lundbeck A/S, H is a Danish pharmaceutical company that develops innovative treatments for brain disorders. As a Senior Research Scientist, you will join the Department of Drug Metabolism within the Non-Clinical Safety Research division.Your key responsibilities will involve evaluating the drug-drug interaction risk of Lundbeck development compounds,...


  • Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full time

    Are you looking for a challenging role in Pharmaceutical Development? Do you have a strong scientific background in physicochemical science, preclinical and/or early phase formulation development and biopharmaceutical science?H. Lundbeck A/S is seeking a highly skilled Drug Product Development Expert to join our Pharmaceutical Development team. In this role,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    ResponsibilitiesThis role includes:Leading or co-leading clinical trials in a therapeutic area for one or more compounds.Collaborating with the Medical Director and other Clinical Research Scientists, as needed.Contributing to the development of the program strategy for assigned trials/compounds and participating in the development of the clinical...


  • Copenhagen, Copenhagen, Denmark Novartis Full time

    Job DescriptionWe are seeking an experienced Medical Lead to join our team at Novartis. The successful candidate will have a strong background in Medical Affairs and will be responsible for ensuring medical enquiries are responded to in a high-quality, timely manner and in accordance with applicable standards.Key ResponsibilitiesTo ensure medical enquiries...


  • Copenhagen, Copenhagen, Denmark Philips Iberica SAU Full time

    Job Title Clinical & Prof. Marketing Manager Job Description As a Clinical & Prof. Marketing Manager , you will support the key account management in serving our customers in the Nordic countries - both in the clinical and commercial area. Your role is: Establishing and maintaining relationships with key opinion leaders in the field of SRC with the aim of...


  • Copenhagen, Copenhagen, Denmark Philips Iberica SAU Full time

    Job Description:Clinical & Prof. Marketing ManagerYour Role:Develop and maintain relationships with key opinion leaders in the field of SRC to successfully place our clinical solutions on the market.Organize and conduct training and educational events for professional societies, patient support groups, clinical staff, and Philips customers to promote product...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Black Swans Exist is seeking a talented Preclinical-Clinical Development Lead to drive the development of our preclinical-clinical projects. As a key member of our team, you will be responsible for overseeing the development and implementation of project strategies, managing project timelines and resources, and ensuring that all project deliverables are...


  • Copenhagen, Copenhagen, Denmark Philips International Full time

    Job TitleClinical Decision Support ExpertAbout the RoleWe are seeking a skilled Clinical Decision Support Expert to support key account management in serving our customers in the Nordic countries. The ideal candidate will have experience in establishing and maintaining relationships with key opinion leaders, organizing training events, and ensuring Philips...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly unique,...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Do you want to play an essential role in ensuring drug product quality throughout its lifecycle and in supporting Novo Nordisk's production of high quality, world-leading diabetes and obesity products? Are you motivated by cross team collaboration, driving optimization and ready to change the game together with colleagues in a dynamic department? Then this...


  • Copenhagen, Copenhagen, Denmark Philips Iberica SAU Full time

    Job DescriptionWe are seeking a Clinical Sales Specialist to support key account management in serving our customers in the Nordic countries - both in the clinical and commercial area. Your Role:Establish and maintain relationships with key opinion leaders in the field of Sleep and Respiratory Care to successfully place our clinical solutions on the...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    Get AI-powered advice on this job and more exclusive features. Delivery Manager | Process Development | Life Science Recruitment Preclinical-Clinical Project Manager Introduction & Purpose Serve as Program Leader for one or more cross-functional program teams, providing strategic leadership and serving as the primary point of accountability for the...