Director, Team Lead, Inspection Readiness

Genmab

Danmark
Kontrakt
Fuldtid

2 måneder siden

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.The Role & DepartmentAs 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

LocationsGenmab 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.About GenmabGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on .Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website .Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

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