- Drive and contribute to implementation activities related to Global Clinical Drug Supply strategies and build of capabilities operationally in collaboration with Global Clinical Drug Supply Planning and Systems teams.
- Drive and participate in maintenance of SOPs for the Global Clinical Drug Supply area with focus on operational aspects related to open-label and double blinded trials.
- Define, lead, organize, and execute cross functional projects driven by Global Clinical Drug Supply Operations team.
- Stakeholder engagement and collaboration related to drug supply operations e.g., GMP QA and CMOs/vendors for packaging, labelling and distribution.
- Contribute to maintenance of CMO landscape and outsourcing strategy for Global Clinical Drug Supply Operations including acting as Vendor Relationship Manager of selected CMOs.
- Develop, implement, and maintain strategical operational plans and approaches for drug supply to clinical trials.
- Provide expertise and insight on operational planning and execution.
- Review timelines and batch orders from Global Clinical Drug Supply Planning and translate into an operational batch plan ensuring timely release of drugs for clinical trials.
- Ensure alignment, planning and coordination of drug supply in collaboration with Global Clinical Drug Supply Planning and Systems teams.
- Drive and support trouble shooting and development of risk mitigation plans.
- Have an oversight of country specific regulations for using trial supplies and ensure compliance and implementation of new regulations.
- Supervise, train, and educate colleagues in Global Clinical Drug Supply Operations.
- Set standards for operational work and compliance and support overall strategic direction and development in department.
- Responsible to be compliant with Genmab ́s quality system.
- Minimum Bachelor's degree or equivalent.
- 6+ years' experience in handling clinical drug supply, including setting up label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.
- Extensive experience in driving and contributing to large cross functional projects with an innovative and entrepreneurial attitude.
- Proficient in leading your leader.
- Experience in working with CMO for clinical trial supplies including vendor governance and management.
- Extensive knowledge and understanding of GMP, GDP, and GCP.
- Proven experience working in teams.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
- Ability to be proactive, enthusiastic, and goal orientated.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support global clinical trial supply strategy.
- Thrives being a role model for others in the department and setting operational standards in an engaging way by coaching colleagues.
- Strong communication skills in English - both oral and written.
- 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
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Associate Director, Global Clinical Drug Supply - Copenhagen, Danmark - Genmab
Beskrivelse
The Role
& DepartmentGenmab is searching for an experienced and energized Associate Director to be part of Global Clinical Drug Supply Operations in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.
Having an impressive pipeline and moving forward with many late-stage trials, the team is building new capabilities by implementing operational models to support new trial designs and optimizing processes.
The Associate Director will have a central role in implementation of GxP processes to support conduct of late phase double blinded trials, and potentially other large cross functional projects/processes in the future, why an analytical mindset and extensive experience with project management of larger projects involving many cross functional stakeholders is key to success in this role.
The Associate Director must be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time for early as well as late-stage clinical trials from an operational perspective.
The position reports to the Global Clinical Drug Supply Operations Lead based in Copenhagen.
Key responsibilities:
Requirements - what you must have
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.
Where you will work
This role is based in either Princeton, NJ USA or Copenhagen, Denmark.
Fully remote applicants will not be considered.
Please indicate if you are willing to relocate if you're not currently living within commuting distance to the DK or US offices.
For US based candidates, the proposed salary band for this position is as follows:
$,.00---$,.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
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.
