Associate Director, Global Drug Safety & Pharmacovigilance Scientist

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.

Role

Perform safety review of Adverse Event reports for Genmab products. Perform ongoing surveillance (including signal detection/evaluation) of safety data from Genmab clinical trials. Be the primary safety contact for other departments and ensure appropriate and timely handling of safety issues. Provide safety review and input to various documents including but not limited to: Trial Protocols, eCRFs/CRFs, and TMFs. Contribute to the development of other documentation such as: Investigator’s Brochures, Subject Informed Consent, and Development Safety Update Reports. Establish and manage external Data monitoring Committees (DMCs) for early phase trials. Contribute to the planning and conduct of Safety Committee activities. Conduct safety training of Genmab employees, CROs, Investigators and other relevant site personnel as necessary. Contribute to multidisciplinary project groups including membership of the Clinical Management Team (CMT) for assigned products. Contribute to the development and optimization of new tools and process. Interact with safety and clinical CROs, perform sponsor oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned products. Oversee Safety Data Exchange Agreements with partners as required. Collaborate with external experts and partners. Perform ongoing surveillance of new and updated regulations/guidelines and assess the impact on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections. Participate in audit and inspection activities as required. Position is hybrid and allows working from home within commuting distance of worksite location. This position requires limited domestic and international travel to client sites.

Please note that Genmab will always pay or exceed the prevailing wage, as determined by the U.S. Department of Labor, when applicable.

Requirements

The qualified candidate must have at least a Bachelor of Science in Pharmacy, Chemistry, Nursing, or a related natural sciences field, or the foreign degree equivalent. The qualified candidate must have at least 5 years (60 months) of progressive, post-baccalaureate experience with all the following: (a) first human trials; (b) overseeing multiple trials with safety inputs at the global level; (c) international experience with internal and external stakeholders; (d) drug safety and/or pharmacovigilance experience; (e) performing ongoing surveillance (including signal detection/evaluation) of safety data; and (f) ensuring compliance with regulatory guidelines and internal processes and procedures in order to be prepared for audits and inspections. All experience may be gained concurrently.

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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

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep pas