Experience Inc. Jobs

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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity