Director, Team Lead, Inspection Readiness

3 weken geleden

Utrecht, Nederland Genmab Voltijd

The Role

& Department

As the inaugural leader of Genmab's clinical Inspection Readiness function, you will be instrumental in cultivating an international team committed to achieving superior inspection readiness across our clinical trials. Your mission will be to oversee the readiness of clinical trial procedures and documents for regulatory scrutiny, ensuring compliance with Good Clinical Practice (GCP) and other relevant standards. Your efforts will be pivotal in smoothing the path for health authority inspections, contributing directly to the swift approval and market introduction of new drugs. This vital role involves ongoing vigilance, enhancement of processes, and strict adherence to the highest standards of documentation and trial management to minimize risks and ensure trials can withstand regulatory examination. 

This strategic leadership role is positioned within the Operational Excellence department of Genmab's Global Development Operations organization, reporting directly to the Head of Clinical Oversight. The role offers flexibility in location, with options in the United States, Denmark, or the Netherlands. 

Key responsibilities include

  • Direct an international team of clinical inspection readiness managers, ensuring strict adherence to Good Clinical Practice (GCP) and leading project management efforts. Foster collaboration with clinical research organizations (CROs), trial teams, and quality assurance experts to achieve exemplary inspection readiness outcomes. Empower team to adeptly support GCP inquiries, assess quality concerns, formulate corrective and preventive actions (CAPA), and manage serious breaches. Supervise strategic planning, documentation, and swift issue resolution arising from health authority inspections and audits 
  • Craft and execute comprehensive inspection readiness strategies on a global scale, maintaining close coordination with trial management and quality assurance teams. Stay abreast of international regulatory developments, serve as the primary point of contact for inspection readiness, and regularly update senior management on progress and challenges. Balance stakeholder needs and organizational dynamics to maintain project momentum and compliance 
  • Utilize key performance indicators (KPIs) to monitor and enhance clinical inspection readiness, aligning efforts with both organizational objectives and regulatory requirements through continuous evaluation against benchmarks and strategy refinement  
  • Enhance inspection readiness processes by partnering with quality assurance to develop training, establish best practices, and spearhead process and system improvements based on audit and inspection feedback. Advocate for the adoption of artificial intelligence to augment inspection readiness and operational efficiency 
  • Drive risk management efforts by identifying and mitigating non-compliance risks across clinical trials, working alongside quality assurance for regular audits and evaluations, ensuring regulatory conformity and trial integrity 
  • Contribute significantly to Genmab’s Inspection Readiness Steering Committee and the Clinical Oversight Leadership Team, driving the growth and development of the clinical inspection readiness function with strategic recruitment and focused talent development, providing leadership, mentorship, and resource management 

Requirements

  • Advanced degree in life sciences, healthcare, or related field 
  • Fluent English (oral and written)
  • 12+ years’ experience in managing clinical trials, focusing on quality assurance, process optimization, and regulatory compliance, with a strong preference for candidates with a background in oncology drug development 
  • Proven leadership in orchestrating international teams, demonstrating a capacity for effective global coordination and team management
  • Solid background in clinical operations compliance and trial master file management within the pharmaceutical or biotechnology sectors 
  • Hands-on experience in sponsor-level inspection readiness, including both front and back-room inspection logistics and operations
  • Expertise in managing document records through electronic trial master file platforms, ensuring efficient and compliant documentation practices
  • Comprehensive understanding of ICH-GCP guidelines and international regulatory frameworks, with a proven track record of applying these standards in clinical research
  • Exceptional relationship-building skills, essential for fostering collaboration and driving proactive compliance activities across diverse teams and stakeholders  

Competencies 

  • Demonstrated ability to transform strategic visions into actionable operational plans, effectively managing daily operations and making critical decisions that influence short to medium-term outcomes 
  • Proven capacity for autonomous decision-making within broad parameters, adept at navigating scenarios with limited precedents or guidelines 
  • Adaptability to excel in fast-paced, evolving environments marked by uncertainty characteristic of a burgeoning company setting 
  • Advanced proficiency in clinical trial management systems and the Microsoft Office suite, paired with a proactive approach to adopting innovative IT and AI technologies 
  • Outstanding skills in communication, strategic planning, and resolving complex cross-functional issues 

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.

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