Senior Clinical Drug Supply Manager
• 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 plans, trial IMP/AxMP forecast and demand plans, and budgets throughout the trial lifecycle
• Maintain all project/program trial level inventory and ensuring no stock out situations.
• Lead and participate in cross functional teams and support strategic cross functional collaboration (i.e., project/program and trials)
• Lead Clinical Project Supply Team discussions.
• Participate in regulatory discussions in relation to IMP/AxMP
• 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
• Support inspection and audit preparation and execution.
• Participate in maintenance of SOPs.
• Responsible to be compliant with Genmab´s quality system. Requirements
• Minimum a bachelor's degree or equivalent.
• Advantage with 6+ years' experience in handling clinical drug supply, including forecasting, demand planning, budgeting, and project planning
• Experience in working with trial management for clinical trial supplies.
• 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 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: $122,000.00---$183,000.00 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 discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can 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!
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