Clinical Drug Supply Manager

2 months ago

København, 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 proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department
Genmab is searching for an experienced Clinical Drug Supply Manager to be part of Global Clinical Drug Supply Operations in Copenhagen, DK or Princeton, NJ in commuting distance to our office locations to work according to our hybrid work arrangement.

Moving forward with many late-stage trials in pipeline, the Clinical Drug Supply Manager will be managing outsourcing of packaging, labelling, and distribution of clinical trial supplies for early as well as late stage Genmab clinical trials. The Clinical Drug Supply Manager will work closely with GMP QA and our CMOs ensuring timely packaging and labelling for our clinical trials as well as IST and PAA for patients with cancer and other serious diseases.

The Clinical Drug Supply Manager must have extensive knowledge of cGMP and have a focus on the level of quality in work performed.

The position reports to the Director of Global Clinical Drug Supply Operations based in Copenhagen.

Responsibilities

  • Manage and coordinate drug supply and to provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
  • Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
  • Set-up English Master Label, manage label translation without vendor and approval of label proofs/designs.
  • Manage set-up of distribution framework through service providers.
  • Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials.
  • Contribute to maintenance of SOPs and Work Instructions in the department.
  • Perform training of other team members.
  • Function as Subject Matter Expert within relevant areas.
  • Responsible for being compliant with Genmab’s quality system.

Requirements

  • At least 3 years’ experience in handling clinical drug supply, including setting up label text and handling of ancillaries.
  • Ability to manage stakeholders internally and externally.
  • Experience working with CMO for clinical trial supplies.
  • Training in GDP, GMP and GCP is a requirement.
  • Experience working with IST and PAA from a Sponsor perspective will be an advantage.
  • Excellent communication skills in English - both oral and written.

Moreover, you meet the following personal requirements:

  • You can structure and organize your work.
  • You are process oriented and contribute to continuous improvements.
  • You have a quality mindset and can prioritize your work in a fast paced and changing environment.
  • You have good interpersonal and communication skills.
  • You can work independently as well as within global teams.
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

The Team
You will be part of a highly competent team focused on packaging and labelling of supplies for clinical trials, working closely with the Global Clinical Drug Supply Planning team and our CMOs.

Together with Global Clinical Drug Supply Systems team the three teams make up the Global Clinical Drug Supply department.

We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.

Application
Has this sparked your interest? Then we encourage you to upload your CV and cover letter including your motivation for this position. We screen candidates on a continuous basis and call in for interviews.

Fully remote applicants will not be considered, so please indicate if you are willing to relocate if you are not currently living in commute distance.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

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.

Location: Copenhagen - Carl Jacobsens Vej 30

Additional location:

  • Princeton, NJ
#J-18808-Ljbffr

  • Clinical Drug Supply Manager

    2 months ago

    København, Denmark Genmab AS Full time

    Clinical Drug Supply Manager Apply Locations: Copenhagen, Princeton, NJ Time Type: Full time Posted On: Posted 4 Days Ago Job Requisition ID: R11309 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...

  • Vice President of Drug Development Data and Analytics

    6 days ago

    København, Denmark Novo Nordisk Full time

       Are you ready for a life-changing career at Novo Nordisk? Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career – you grow professionally, and you impact the lives of our patients for better.  Novo Nordisk is a global healthcare company with more than 100 years of driving change for better health and is...

  • Scientist for ADME studies in the Department of Drug Metabolism

    2 months ago

    København, Denmark H. Lundbeck AS Full time

    Do you have a passion for LC-MS and like to work with “state of the art” technologies? Do you thrive with scientific challenges? Then you may be our new colleague. Your new role – why is this a great opportunity? You will be responsible for planning, conducting, and reporting of in vitro and in vivo ADME studies, including metabolite profiling and...

  • (Senior) Manager, Global Drug Safety

    2 months ago

    København, 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...

  • Sr. Associate/Manager, Clinical Trial Disclosure

    2 months ago

    København, Denmark Genmab AS Full time

    Sr. Associate/Manager, Clinical Trial Disclosure & Transparency Sr. Associate/Manager, Clinical Trial Disclosure & Transparency Location : This role can be based in Copenhagen, Denmark (DK), or Utrecht, Netherlands (NL), and offers a hybrid work arrangement. Role Overview As a Sr. Associate/Manager in the Clinical Trial Disclosure & Transparency team, you...

  • Senior Clinical Research Scientist, Solid Tumor Team

    2 months ago

    København, 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...

  • Senior Quality Engineering Architect, R&D Research

    2 months ago

    København, 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...

  • Clinical & Prof. Marketing Manager

    4 weeks ago

    København, 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...

  • Manager/Senior Manager, GCP Quality

    2 months ago

    København, Denmark Ascendis Pharma AS Full time

    Join the GCP Quality team in a leading and fast-growing biotech company. Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives....

  • Sr. Associate/Manager, Clinical Trial Disclosure

    2 months ago

    København, 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...

  • Customer Service Manager

    3 weeks ago

    København, Denmark JACOBS DOUWE EGBERTS Full time

    Are you ready to lead and develop our amazing customer service team? Do you have a passion for developing and implementing improvements to optimize the supply chain flow to our customers? Then you might be the new colleague we are looking for. Our current Customer Service Manager is moving to a new exciting role in Supply Chain, and we are therefore...

  • (Senior) CMC Technical Integration Manager

    2 months ago

    København, Denmark Genmab AS Full time

    The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at (Senior) CMC Technical Integration Manager Locations: Copenhagen Time Type: Full time Posted on: Posted 2 Days Ago Job Requisition ID: R11639 At Genmab, we’re committed to building extraordinary...

  • Clinical Development Specialist

    2 months ago

    København, Denmark Abbott Laboratories AS Full time

    Clinical Development Specialist Placering GlostrupAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. What You Will Do Advocate for Abbott solutions on a senior clinical support level, in new installations of...

  • Clinical Research Associate

    2 months ago

    København, Denmark MSD Danmark ApS Full time

    Placering Copenhagen Job Description We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach...

  • Associate Director, Global Clinical Trial Manager Genmab On-site Princeton

    2 months ago

    København, Denmark MeetFrank Full time

    Associate Director, Global Clinical Trial Manager 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. We believe that being proudly unique, determined to be our best, and authentic is...

  • Associate Clinical Research Associate

    2 months ago

    København, Denmark MSD Danmark ApS Full time

    Placering CopenhagenJob Description Associate Clinical Research Associate (aCRA) About the Position We are currently seeking a skilled and motivated Associate Clinical Research Associate (aCRA) to join our team. This position is with Our Company in Denmark, a leading pharmaceutical company. As an aCRA, you will be an integral part of a dedicated team...

  • Global Regulatory Lead

    2 months ago

    København, Denmark Ferring Pharmaceuticals AS Full time

    Are you an experienced Regulatory Affairs Professional, and do you want to help drive the development of the current and next generations of Ferring’s health care solutions that help people live better lives? Then come join us in a challenging position in one of our Global Regulatory Affairs Therapeutic Area teams. Ferring is dedicated to advancing...

  • Vice President of R&ED Data and Analytics

    6 days ago

    København, Denmark Novo Nordisk Full time

       Are you ready for a life-changing career at Novo Nordisk? Working at Novo Nordisk is never just a job, it is an opportunity to have a life-changing career – you grow professionally, and you impact the lives of our patients for better.  Novo Nordisk is a global healthcare company with more than 100 years of driving change for better health and is...

  • Demand & Supply Planner

    2 weeks ago

    København, Denmark JACOBS DOUWE EGBERTS Full time

    Are you the Demand & Supply planner we are looking for? Are you driven by our passion to give our customers the best possible Supply Chain experience there is? Do you hold experience within Supply or are you newly graduated within Supply Chain Management? Then keep reading to see if this could be the next step in your career. We are now looking for a...

  • Account Manager Ultrasound

    2 months ago

    København, Denmark Philips Iberica SAU Full time

    Job Title Account Manager Ultrasound Job Description In this role, you have the opportunity to make life better: Market Philips ultrasound products and solutions to Danish hospitals and health care professionals. Collaborate with Philips colleagues in Denmark as well as Nordics to deliver the best customer experience. Be part of a global organization...