Global Clinical Supply Chain Director
4 weeks ago
At Genmab A/S, we are seeking a highly experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ.
This is an exceptional opportunity for a talented professional to play a key role in the management of clinical trial supplies, ensuring timely and compliant delivery of high-quality products to patients with cancer and other serious diseases.
The successful candidate will have extensive knowledge of cGMP regulations and guidelines, as well as experience in managing outsourcing of packaging, labeling, and distribution of clinical trial supplies.
Key Responsibilities:
- Manage and Coordinate Drug Supply: Provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
- Ancillaries and Comparators Management: Coordinate setup and management of ancillaries, pre-medication, and comparators for clinical trials.
- Label Translation and Approval: Set up English Master Label, manage label translation without vendor approval of label proofs/designs.
- Distribution Framework Setup: Manage setup of distribution framework through service providers.
- SOP Maintenance: Contribute to maintenance of SOPs and Work Instructions in the department.
- Training and Subject Matter Expertise: Perform training of other team members and function as Subject Matter Expert within relevant areas.
- Compliance: Responsible for being compliant with Genmab's quality system.
The ideal candidate will have at least 3 years' experience in handling clinical drug supply, including setting up label text and handling of ancillaries. Strong stakeholder management skills and experience working with CMOs for clinical trial supplies are also required.
We offer a competitive salary ranging from $120,000 to $180,000 depending on location and experience, as well as a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
Genmab A/S is committed to fostering a diverse and inclusive work environment where all employees feel valued and supported. We believe that our differences are what make us stronger and more innovative, and we are proud to be an equal opportunities employer.
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