Associate Director, GDS&PV Signal Detection - Princeton, United States - Genmab

Description

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.

As our Associate Director, you must effectively implement Signal Management Group surveillance strategies for proactive and systematic detection and evaluation of new safety signals and emerging trends from clinical and post-marketing safety data for complex pharmaceutical products (e.g., large innovative programs, new therapeutic areas, or complex business partner relationships).

These activities include the evaluation, piloting, as well as use of novel, computer-assisted tools and methodologies for signal detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, e.g., claims and electronic medical records.

This position develops and implements product-specific surveillance plans, performs clinical and post-marketing signal detection activities, including signal validation, and participates in communication of emerging signals in forums. This position will also participate in the development of strategies for signal evaluation, including providing guidance on data sources and methods of analysis. The position may also perform activities supporting signal evaluation, such as ad hoc data mining of FDA FAERS, WHO VigiBase, and EMA EudraVigilance databases.

Key Responsibilities

· Identify and assess (validate) new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports. This includes signal detection activities in safety platforms.

· Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.

· Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc.

· Serve as an expert for internal signal-tracking tool and continues to build functionality to in-house tools.

· Responsible for the data mining process, implementation of data mining and coordinating data mining runs and tracking outputs and signals.

· Creates signal management strategy for department through process improvement and lessons learned.

· Prepare reviews of topics and summary analysis reports of safety data, with minimal guidance. Provide recommendations for further signal evaluation in a timely manner.

· Work with key business partners in developing and implementing product-specific surveillance plans.

· Participate as member of the matrix teams to address product specific safety issues, assist in the development of signal evaluation strategies, and participate in signal evaluation.

· Communicate findings from routine and ad-hoc signal detection and assessment activities.

· Responsible to develop and implement programmatic surveillance of adverse event reports for potential safety and product quality issues.

· Assist in the evaluation of novel, computer-assisted tools and methodologies for analysis of safety data, including piloting new data source and methodologies.

· Contributes to submission related documents (labeling documents, REMS/RMPs, etc)

· Trains staff on signal detection activities and signal management processes

· Maintain a state of inspection readiness

Requirements

· Advanced Healthcare-related Degree (e.g., RN, PA, PharmD) with

· Minimum requirement: 5+ years of industry experience in drug safety or related area required.

· Understanding of global health authority regulations and guidances surrounding the processing, reporting and evaluation of adverse events is required.

· Understanding in single case processing, aggregate data review and evaluation of drug safety issues, adverse event dictionaries, literature publications, core labeling, and Periodic Safety Review preparation is required.

· Ability to present complex data in a concise and understandable scientific manner is required.

· Familiarity with applied epidemiologic principles of case series evaluation and understanding of computer-assisted methodologies for safety data analysis is preferred.

· Knowledge in public health surveillance and tools (relevant work experience or Masters Public Health or equivalent) is preferred.

· Knowledge of statistics, or system analytics, information systems engineering, or machine learning is preferred.

· Ability to process data with Excel and SAS JMP is preferred.

· Ability to lead projects utilizing analytical approach is preferred.

· Ability to thrive in a global, matrix environment.

This role is hybrid and requires you to be in the Princeton, NJ office 3x per week.

Additional Job Description

· Provide inputs for identification/definition and implementation of drug safety solutions/SOPs within area (compliance/ data management/ safety ops) to ensure robust, scalable, and efficient outcomes

· Engage with cross-functional teams (e.g. IT, research teams, data science, clinical ops) to support, guide/advise, and drive design/implementation of solutions/SOPs

· Support appropriate management of assigned global pharmacovigilance procedures within area (compliance/ data management/ safety ops)

· Guide resolution of critical requirements, issues, and escalations as applicable (e.g. CAPA process resulted from compliance, investigational and marketed product safety surveillance, standardization of safety reporting processes, metrics analysis and reporting)

· Drive appropriate and timely documentation within own area (e.g. safety reporting forms, SOPs, internal/external guidance documents) in collaboration with relevant cross-functional teams (e.g. QA, DS)

· Participate in key engagement and oversight activities with vendors/contractual partners within area

· Engage, as directed, with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts and partners around emerging landscape; regulatory authorities)

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

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 (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.