Act as Clinical Drug Supply Manager, of the following tasks:

Global Clinical Drug Supply Project/Trial Management

• Obtain Project/Trial specific information to initiate drug supply strategic planning and execution, and maintain information on changing clinical development plan

• Identify risks for delays for projects/programs and trials and possible mitigations (contingency plans and new/additional scenarios) that may impact clinical drug supply)
• Create and maintain program/project and trial IMP/AMP forecast and demand plans throughout the trial lifecycle
• Maintain all project/program trial level inventory and ensuring no stock out situations
• Create and maintain program/project and trial budget forecast throughout the trial lifecycle
• Lead and participate in cross functional teams (CDTs, CSTs, CTTs, CMC) and support strategic cross functional collaboration (i.e., project/program and trials
• Lead/Participate in Clinical Project Supply Team discussion
• Participate in regulatory discussions in relation to IMP/AMP
• Manage project/trial specific planning documentation (i.e., drug supply plan, milestone tracking, IMP manual, etc.
• Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, and deliverables

Global Clinical Drug Supply:

• Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation area including implementation of new regulations in the department
• Provide SME knowledge support
• Coach and mentor colleagues during onboarding and maintenance of training
• Responsible for oversight and resolution of deviations, CAPAs and change controls in connection to Clinical Drug Supply Operation
• Drive Inspection and Audit preparation and execution
• Responsible to be compliant with Genmab’s quality system

Requirements

• Minimum a Bachelors with 3-5 years experience.  Master’s degree with +2 years experiences, or PhD’s degree with +1 year of experience, or equivalent of experience.
• Experience in handling supply chain, manufacturing, ERP, clinical supply chain, operations, logistics, preferably in the pharmaceutical or biopharmaceutical industry.
• Broad and Diverse experience in working with trial management for global clinical drug supply and supply functions
• Knowledge and understanding of GMP, GDP, and GCP. Supply Chain systems and processes.
• Strong desire to exploit emerging technologies for better business outcomes.
• 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 the execution of tasks.
• Strong communication skills in English - both oral and written.

The Team

You will be part of a highly competent team focused on planning and maintenance of supplies for clinical trials, working closely with the Global Clinical Drug Supply Operations & System team and our cross-functional stakeholders.

Together with Global Clinical Drug Supply Operations & 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.

For US based candidates, the proposed salary band for this position is as follows:

$95,625.00---$159,375.00

The 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

• 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

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.

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. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.