Team Lead, Clinical Drug Supply
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.The Role
Genmab is searching for an experienced Team Lead in Clinical Drug Supply to be part of CMC Operations in Copenhagen, Denmark. CMC Operations manages the timely manufacture of GMP produced trial supply from DNA vial drug product to IMP for Genmab’s clinical studies. The Team Lead, Clinical Drug Supply is responsible for leading the Clinical Drug Supply unit with its main tasks of managing clinical trials supplies of IMP from first in human trials to late stage registration trials.Key Accountabilities
The responsibilities of the Team Lead, Clinical Drug Supply will include, but not be limited to:
- Leading the Clinical Drug Supply unit
- Set up global IMP supply strategies for Genmab’s clinical studies
- Set up global IRT strategy
- Drug supply forecasting, inventory oversight and IRT/IWRS maintenance
- Continuous improvement of drug supply workflow
- Ensuring compliance to applicable GxP regulations and internal quality system
- Authoring and reviewing documents e.g. IMP Manuals and internal GxP documents
- Managing and coordinating drug supply to provide IMP for clinical trials
- Label set-up for specific countries and approval of labels
- Managing shipping and distribution through service providers
- Defining and managing appropriate drug supply activities at CMO’s necessary for providing drug supplies for clinical trials
- Participation in CMC and Clinical Management Teams
- Support CMC and Clinical Project Managers as required
- You have preferably experience in leading a team of drug supply specialist
- You have a minimum of five years’ experience in handling clinical drug supply, including setting up labels and text, and distribution with cold chain management
- You have experience in setting up and working with IRT systems
- You have experience in working with CMO’s for the clinical trial supplies
- You are trained in GDP and GMP
- You are structured and process oriented
- You have a quality mindset and can prioritize your work in a fast paced and changing environment
- You have proven strategic skills in setting up global clinical distribution
- You have good interpersonal and communication skills
- You demonstrate active stakeholder management to improve the effectiveness of a team and its workflow
- You can work independently as well as within global teams
- You are both result and goal oriented and committed to contributing to the overall success of Genmab.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Uthen Khamproh (email@example.com).
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To learn more about Genmab, you can visit our website: http://www.genmab.com