Senior Director, Head of 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

• 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

• 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

• 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

• 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

• 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

Genmab