Associate Director, Global Drug Safety - Utrecht, Nederland - Genmab

Beschrijving

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 & Department

Genmab is on the lookout for dynamic professionals to oversee the safety aspects of its pharmaceutical products and clinical trials. In this crucial role, the incumbent will be at the forefront of monitoring, evaluating, and ensuring the safety of Genmab's products, playing a pivotal part in safeguarding the well-being of patients and maintaining the company's stringent safety standards.

Key Responsibilities Include:

Safety Review & Surveillance: Undertake meticulous safety reviews of adverse event reports related to Genmab products. Engage in continuous surveillance activities, including signal detection and evaluation of safety data from Genmab's clinical trials in collaboration with the safety physician.

Safety Liaison & Documentation: Serve as the primary point of contact for safety-related matters across various departments, ensuring timely and appropriate resolution of safety issues. Provide expert safety input and review for a range of documentation, such as Trial Protocols, eCRFs/CRFs, and TMFs, as well as contribute to the creation of documents like Investigator's Brochures, Subject Informed Consent, and Development Safety Updates.

Safety Oversight & Training: Oversee the management of external Data Monitoring Committees (DMCs) for early-phase trials. Lead and participate in Safety Committee activities. Deliver comprehensive safety training to Genmab employees, CROs, Investigators, and other pertinent site personnel.

Cross-Functional Collaboration & Process Enhancement: Engage actively in multidisciplinary project groups, holding membership for assigned products. Drive the development and refinement of new tools and methodologies within the realm of Drug Safety. Collaborate with safety and clinical CROs, oversee sponsor activities related to safety, process invoices, and ensure unwavering compliance with regulatory reporting requirements for designated products.

Partnership Management & Regulatory Compliance: Manage Safety Data Exchange Agreements with partners as needed. Foster collaboration with external experts and partners. Guarantee strict adherence to regulatory guidelines and internal protocols, preparing meticulously for audits and inspections. Participate actively in audit and inspection undertakings when required.

Requirements - What You Must Have:

Experience & Expertise: A minimum of 6 years of pertinent experience in Clinical or Drug Safety and Pharmacovigilance. Demonstrable expertise in medical safety operations, including signal detection, risk management, and periodic reporting. Oncology experience is a significant plus.

Regulatory Knowledge: Proficient understanding of and experience with FDA/EMA/PMDA/ICH requirements, good clinical practices, and the nuances of pharmaceutical clinical development. Proven track record in supporting internal audits, readiness for inspection, and interactions with regulatory agencies.

Project Management & Skills: Proven capability in planning, orchestrating, and managing multiple projects simultaneously. Essential skills include data analysis, critical thinking, problem-solving, teamwork, and exceptional communication and presentation abilities in English (both oral and written).

Adaptability & Efficiency: Ability to thrive in a fast-paced, innovative environment while maintaining flexibility, a proactive stance, resourcefulness, and efficiency.

This role at Genmab offers a unique opportunity to contribute significantly to the safety and efficacy of groundbreaking medical products in a dynamic and supportive environment. We seek individuals who are passionate about making a difference in the world of pharmaceuticals and are ready to take on this challenging yet rewarding role.

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.

About Genmab

Genmab 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 (KYSOTM) 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 inclusion

We 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 our website.

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.