Clinical Drug Supply Manager

Employer: GENMAB

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off 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.

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

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.