Overview
In this role, you lead Clinical Trial Managers and Clinical Trial Associates to ensure high-quality trial execution within the Clinical Operations function. You provide strategic guidance, mentorship, and resource planning to align delivery with Genmab’s development goals. You may take on Global Trial Lead responsibilities to manage demand fluctuations and cross-functional collaboration. Your leadership supports process improvements, training, and compliant trial execution in a fast-paced, science-driven environment. This position offers a chance to shape development operations and impact cancer and serious disease programs at scale.
Arbeidsvoorwaarden / Benefits- 401(k) plan with 100% match on the first 6%
- Health benefits: medical, dental, vision
- Paid vacation, sick leave, holidays, and parental leave
- Backup care and family support programs
- Tuition reimbursement
- Lifestyle Spending Account for wellness and personal expenses
Verantwoordelijkheden- Direct and develop CTMs and CTAs, including performance evaluations and career growth planning
- Ensure adequate resourcing, workload balance, and succession planning within the team
- Foster cross-functional collaboration and knowledge-sharing within clinical operations
- Collaborate with Global Trial Leads on trial activities for direct report teams
- Support trial deliverables through coaching and mentorship of CTMs/CTAs
- Advise on resource needs and contribute to trial resource planning
- Set clear expectations, guide performance, and drive competency development
- Lead functional working groups and act as SME within Clinical Operations
- Support training initiatives across Trial Operations
- Collaborate with senior leadership to implement best practices in Development Operations
- Ensure adherence to GCP/ICH and regulatory requirements (FDA, EMA)
- Develop and refine SOPs to optimize efficiency and compliance
- Support audits, inspections, and regulatory interactions and ensure inspection readiness
- Identify and drive process improvements for trial execution and data quality
- Lead cross-trial initiatives (CAPAs, new process rollouts) across the program
- Oversee CTM/CTA task execution and promote practical process implementation
- Collaborate across functions to drive efficiencies and provide day-to-day guidance for CTM/CTA groups
Belangrijkste vereisten- Bachelor of science degree with relevant specialization; Master of science degree preferred
- 12+ years in clinical operations
- Experience leading complex global clinical projects/programs
- Experience managing cross-functional and CRO/regulatory teams
- Operational management and budget planning experience
- Global clinical program level experience
- Oncology experience preferred
- 2+ years as Clinical Operations representative in CDTs or GPTs preferable
- Experience leading teams in a global matrix environment with tools/tech to meet business needs
- Strategic thinking to optimize resources for program execution
- Excellent English communication (written and spoken)
- Dedicated team player
- Trust-building leadership
- Quality mindset
- GCP and ICH knowledge
- CAPA and process improvement
- SOP development and regulatory inspections
Solliciteren