Senior IRT/ Systems Manager, Clinical Drug Supply (Hybrid)

The Role

Department

Genmab is now searching for an experienced Senior IRT / Systems Manager to be part of Global Clinical Drug Supply, CMC Operations, and work according to our hybrid work arrangement in Princeton, NJ.

Responsibilities

Act as Senior IRT Manager, Global Clinical Drug Supply, responsible for the following tasks :

• IRT Platform Management
• Lead and support setting of IRT standards, best practices, training, and support on partnership with IRT governance for internal and external purposes.
• Manage governances’ standards with IRT vendors and identify trends for use of IRT to streamline & support strategic development and reducing overall timelines.
• Responsible for technical oversight, compliance, qualification, and validation of IRT systems used in Genmab. Ensure all IRT systems maintain qualified state throughout system lifecycle.
• Identify and manage changes rolled-out by IRT vendors.
• IRT Portfolio & Project (i.e., Trials) Management
• Responsible for the lifecycle (set-up, maintenance, and decommissioning) of trial specific IRT systems including :
• Plan and coordinate the IRT implementation (initial / amendments), design requirements, UAT planning & execution, integrations, documentation, and training in accordance with trial protocol and timelines with the relevant cross-functional stakeholders.
• Enforces the use of IRT system standards.
• Mitigates risk related to IRT system implementation through proper risk assessments.
• Manage and maintain internal and external stakeholder’s expectations for IRT service and system delivery.
• Manage multiple projects concurrently, manage project schedules, and ensure quality deliverables in a dynamic environment.
• Communicate effectively with stakeholders on project status and coordinate activities with the clinical trial teams, as necessary.
• Participates in or leads Genmab operational planning sessions.
• IRT Vendor Management
• Supplier Relationship manager for IRT vendors.
• Provide inputs to KPIs & metrics for trend analysis of potential and current risks / issues.
• Participate in IRT vendor operational oversight activities for assigned clinical trials.
• Collaborate closely with IRT vendor project manager for assigned trials.
• Provide input and / or participates in IRT Vendor audits and inspection readiness activities.
• Provides support for problem resolution, root cause analysis, corrective actions between IRT vendor and clinical trial teams.
• Continuous Improvement
• Identifies areas for continuous improvement.
• Lead assigned improvement activities.
• Provide mentoring and training to IRT team members as well as facilitate cross functional training for improvement / initiative rollouts.
• May provide support for the creation / maintenance of documentation, such as, but not limited SOPs, work instructions, and job aids.
• Other Responsibilities
• Ensures the quality and inspection readiness of all Genmab IRT systems.
• Supports the records retention and clinical data maintenance.
• Responsible to be compliant with Genmab s quality system.

Key requirements

• Bachelor's degree in science or related technical area, or equivalent. Advanced degree / certification preferred.
• 6-8 years of experience in supply chain or related area in pharmaceutical, biotechnology, and / or medical device industry.
• Significant experience in drug supply chain management.
• Significant experience in working with applicable regulatory standards e.g., GMP, GCP, ICH guidelines.
• Experience in managing large / complex projects.
• Demonstrated experience in working with multi-functional and multi-cultural teams.

Where you will work

This role is based in Princeton, NJ and requires working onsite in the Princeton office according to Genmab's hybrid work schedule (3 days onsite / 2 days work-from-home).

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

$0.00 $0.00

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.