Job Description

Job Description

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 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. 

Key Responsibilities:  

Global Clinical Drug Supply:  

• Set standards for drug supply planning, while ensuring compliance and support 

overall strategic direction and development of the department 

• Develop standards and assumptions IMP/AMP forecast and demand planning per Project/Trial portfolio 

• Drive development and maintenance of SOPs for the Global Clinical Drug Supply Planning area including implementation of new regulations in the department 

• Lead continuous improvement initiatives and changes related to the overall GCDS team and GCDS Planning strategic plans 

• Ensure strong collaboration throughout all Global Clinical Drug Supply (Planning (Early & Late-Stage Team), Operations, Systems, and Strategy & Innovation) 

• Stakeholder management and collaboration at an internal company leadership level including, but not limited to, Development Operations, CMC, Project Portfolio Management, Medical, and enabling functions + external partners including collaborators, CMOs, and enabling vendors. 

• Implement lessons learned from the portfolio through initiatives, process changes, and ways of working. 

• Provide SME knowledge support

• Responsible for oversight and resolution of deviations, CAPAs and change controls in connection to Clinical Drug Supply Planning 

• Responsible for inspection and audit as representative Global Clinical Drug Supply 

• Drive Inspection and Audit preparation and execution 

• Responsible to be compliant with Genmab’s quality system 

People Management:  

• Manage Global Clinical Drug Supply Team - Planning team members (directly or in-matrix manner) 

• Drive leadership and guidance to Global Clinical Drug Supply - Planning members 

• Point of contact for escalations related to Drug Supply Planning, and other GCDS areas as needed 

• Supervise, coach and mentor colleagues during onboarding and maintenance of training 

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 

• Develop, implement, and maintain strategical operational plans and approaches for drug supply to clinical trials. 

• Ensure continuous and consistent communication between Global Clinical Drug Supply functions (Planning, Operations, System, and Strategy & Innovation) to ensure no stock-outs and timely delivery of clinical trial supplies 

• Ensure the reduction of wastage and target high levels of cost-savings per projects 

• 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 

• Aggregate IMP/AMP forecast and demands on project/program level

• 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 

• Collaboration with Sr. Management, CMC, CDTL, DPM, and CTT Members 

• Lead and participate in cross functional teams (CDTs, CSTs, CTTs, CMC) and support strategic cross functional collaboration (i.e., project/program and trials) 

• Lead 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 

The position reports to the Director, Global Clinical Drug Supply Planning Lead based in Princeton, NJ USA.

Requirements:  

• Minimum of a bachelor’s degree or equivalent. 

• 10+ years’ experience in handling clinical drug supply, including forecasting/demand planning, work with cross-functional stakeholders, budgeting, regulatory and quality, and partnership managmeen t 

• Extensive experience in driving and contributing to large cross functional projects with an innovative and entrepreneurial attitude. 

• 5+ years’ experience in people 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. 

Where you will work  

• This role can be 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:

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. 

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. 

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Job Tags

Similar Jobs