Associate Director, Global Drug Safety and Pharmacovigilance at Genmab in Princeton, New Jersey

Job Description:

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.

Job Description

Serve as the safety expert accountable for the global safety strategy and overall safety profile for assigned Genmab products (investigational) throughout their lifecycle, including leading all major pre- and post-marketing safety related deliverables, including signal, benefit-risk evaluation and risk management activities. Interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. Work together with other Drug Safety (DS) staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. Perform medical review of Adverse Events reports for Genmab products. Perform ongoing surveillance of safety data for Genmab products from different sources. Ensure handling of safety issues and implementing risk mitigation activities. Perform medical review and provide input to different documents e.g. Trial Protocols and amendments, Clinical Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator's Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, etc. Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds. Responsible for establishment and management of external Data monitoring Committees (DMCs). Position allows working from home within commuting distance of worksite location.

Job Requirements

The qualified candidate must have a Doctor of Medicine degree or foreign equivalent degree. The qualified candidate must have at least 10 years (120 months) of Drug Safety/Pharmacovigilance and clinical development experience. The qualified candidate must have at least 10 years (120 months) of experience with all of the following: (a) global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP); (b) working with the FDA and other regulatory authorities; (c) individual adverse event case report processing, triage and medical review; (d) safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems; (e) MedDRA, and MedDRA and WHODrug coding dictionaries; (f) PV audit process with active participation in Regulatory Authority Inspections; (g) drug development process; (h) utilizing the following technologies: Microsoft Excel, PowerPoint and Word. Position allows working from home within commuting distance of worksite location. All experience may be gained concurrently

For US based candidates, the proposed salary band for this position is as follows:

$142,500.00---$237,500.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

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 (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 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 https://www.genmab.com/privacy .

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.