Senior Director, Head of Clinical Oversight

The Role

Genmab is seeking a Senior Director for the role of Head of Clinical Oversight. This leadership role will be at the forefront of establishing strategic vision and supervising the comprehensive management of clinical oversight functions across development operations. The scope may include and is not limited to, ensuring excellence in trial master file oversight, spearheading inspection readiness, enhancing trials’ oversight with vendors, and fortifying risk management strategies. This position demands active collaboration with a broad spectrum of cross-functional and international teams to achieve outstanding outcomes and advance initiatives that synchronize our clinical oversight endeavors with Genmab's strategic objectives. Reporting directly to the Vice President of Operational Excellence within the Global Development Operations organization, this role offers the flexibility of location, with positions available in the United States, Denmark, or the Netherlands. 

Key Responsibilities include

Strategic leadership and innovation in clinical oversight 

• Translate Global Development Operations' strategic vision into practical plans for clinical oversight, leading integrated teams to ensure the accuracy and compliance of clinical trial data for decision-making, regulatory approvals, and market entry  
• Cultivate excellence in quality, risk management, and continuous improvement in clinical oversight, while fostering collaborations across development operations (e.g., trial management, site engagement & feasibility, data management, digital development, vendor management), quality assurance, compliance & risk, and other enabling functions  
• Enhance clinical oversight through rigorous key performance indicator (KPI) analyses, driving improvements, setting benchmarks, and aligning strategies with organizational goals and regulatory standards 
• Champion the adoption and integration of innovative technologies like automation and artificial intelligence in collaboration with data science and IT teams to elevate operational efficiency and clinical operations 
• Play a pivotal role in the Operational Excellence Leadership Team, and lead the Clinical Development Process Expert Group to spearhead process innovations and cross-functional standardization 
• Direct growth and skill development across clinical oversight functions, emphasizing strategic hiring, resource optimization, and mentorship for enduring success and innovation 

Inspection readiness and trial master file oversight  

• Lead inspection readiness and trial master file oversight with a strategic focus on Good Clinical Practice compliance and regulatory excellence, ensuring operational integrity across clinical operations 

• Champion project management and collaborative excellence in inspection readiness, driving strategic planning, compliance management, and effective resolution of audits and regulatory inquiries 

• Architect and implement trial master file strategy in alignment with regulatory standards, promoting seamless inspection readiness and the integrity of clinical documentation 

• Enhance clinical document management by adopting master data and artificial intelligence, driving efficiency, automation, and the implementation of best practices throughout development operations 

• Cultivate strategic alliances and champion Good Documentation Practices, steering continuous process and system improvements to uphold data integrity and compliance 

Trials’ vendor oversight and risk management  

• Lead a multidisciplinary team to uphold clinical trial data integrity and compliance with Good Clinical Practice, focusing on risk management, centralized monitoring, and rigorous vendor oversight, including close collaboration with clinical research organizations (CROs) to support decision-making and secure global regulatory and market approvals 

• Foster a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue resolution, risk mitigation, and continuous improvement through strategic partnerships with CROs and vendors across all phases of drug development 

• Implement a strategic oversight framework that integrates a proactive, risk-based management approach with CROs to enhance trial quality, compliance, and inspection readiness, leveraging CRO expertise and capabilities in alignment with Genmab’s clinical trials portfolio 

• Identify, assess, and mitigate risks in collaboration with CROs across global trial operations, using advanced analytics to refine protocol designs, optimize monitoring strategies, and ensure robust data management, while proactively developing contingency plans for trial execution 

• Enhance collaboration with quality assurance and process stakeholders to streamline SOPs and trial governance, adapting to evolving regulatory landscapes and ensuring alignment with organizational goals, with a particular focus on managing and overseeing CRO performance to maintain the highest quality and compliance standards 

Requirements

• Advanced degree in life sciences, healthcare, or related field 
• Fluent English (oral and written) 
• 15+ years’ experience in the biotech/pharmaceutical industry with extensive experience in clinical development, operations (e.g., site, sponsor, CRO), and project management 
• 10+ years’ experience leading cross-functional teams, preferably within matrix organizations, complemented by a solid history of managing global, multisite operations and exceptional people management skills 
• Strong foundation in oncology drug development, adept in clinical operations, with a comprehensive understanding of ICH-GCP standards and SOPs 
• Proficient in managing inspections, audits, clinical documentation, vendor oversight, centralized monitoring, and implementing risk management strategies 
• Technically skilled in using clinical trial management systems and Microsoft Office, with a keen interest in leveraging innovative IT and AI solutions, coupled with insight into current trends and future directions of health authorities 

Competencies  

• Exceptional leadership and communication skills, capable of influencing senior management and fostering international collaboration without direct authority

• Strong problem-solving, negotiation, and conflict resolution skills, with the ability to navigate complexity and achieve tangible outcomes 
• Advanced project management abilities, proficient in prioritizing multiple tasks and adapting to changing timelines while maintaining team accountability 
• Expertise in building stakeholder relationships, driving employee engagement, and motivating diverse, global teams in a matrix environment 
• Effective at leading cross-functional change projects and managing through ambiguity in a dynamic setting, with a high energy level and relentless optimism toward achieving goals 

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.