Sr. Associate/Manager, Clinical Trial Disclosure

1 week ago

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

Genmab is committed to promoting transparency in clinical trial research. We recognize the scientific and ethical value of sharing clinical trial information in an unbiased and timely manner, benefiting patients and external stakeholders alike. Our Clinical Trial Disclosure & Transparency (CTD&T) team, part of Development Operations, plays a crucial role in ensuring successful clinical trial conduct and reporting.

We are now expanding our CTD&T team with a Sr. Associate/Manager position. You will get a unique opportunity to join a collaborative team of passionate and innovative colleagues.

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 will be responsible for executing global and national clinical trial disclosure requirements across Genmab's entire portfolio. Your key responsibilities include supporting trial teams, ensuring high-quality disclosure of clinical trial information, implementing new transparency requirements, and overseeing the relationship with our disclosure vendor(s) to ensure efficiency and compliance.

Key responsibilities

  • Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.
  • Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS.
  • Author or oversee the development of plain language results summaries.
  • Develop and update SOPs, templates, and oversee applicable system implementations.
  • Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
  • Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines.
  • Management of unsolicited requests via the clinicaltrials@genmab.com mailbox.

Requirements

  • Previous experience with clinical trial disclosure.
  • Bachelor's degree minimum.
  • 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
  • Excellent written and verbal communication skills.

Moreover, you meet the following personal requirements:

  • Engaged colleague with a positive and collaborative mindset.
  • Goal- and improvement-oriented with proven track record of deliveries against set timelines.
  • Strong organizational skills with ability to plan and prioritize tasks.
  • Proven ability to work with a high level of integrity, accuracy, and attention to details.
  • Committed to contributing to the overall success of Genmab.

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 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.

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.

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.

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.

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.

Location: Copenhagen - Carl Jacobsens Vej 30

Additional location:

  • Utrecht

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