- Socks-Off (KYSOTM) antibody medicines.
Senior Manager Risk Based Monitoring, Trial Strategy and Delivery - Princeton, United States - Genmab A/S
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.
The Role & DepartmentThe Senior Manager Risk Based Monitoring, Trial Strategy and Delivery will be responsible for supporting the CTTs in timely planning and execution of Risk Based Quality Management deliverables in accordance with standard operating procedures (SOPs), policies and practices from study start-up, during conduct to closure.
The Senior Manager Risk Based Monitoring will join the RBQM team, Trial Strategy and Delivery and support the CTTs with development of Risk Assessment and Mitigation Plan (RAMP), identification of critical to quality factors, Parameters with Quality Tolerance Limits (PQTLs), Key Risk Indicators (KRIs), thresholds for action and monitoring tactics, as well as identification of de-risking initiatives and mitigation activities.
The Senior Manager Risk Based Monitoring will closely collaborate with relevant RBM vendor to ensure proper implementation of applicable RBQM model selected for the study according to agreed roles and responsibilities between Genmab and RBM vendor.
Responsibilities As a Senior Manager Risk Based Monitoring you will drive and/or independently perform:Support the CTT during development of trial protocol and study set-up in decision on which data and processes are critical and whether any of the associated risks can be mitigated through quality by designDrive the discussions within CTT to identify critical data and process, associated risks and monitoring strategies including monitoring triggers/thresholdsHave a key role in bringing together all the relevant skill areas involved in monitoring activitiesMonitor Key Risk Indicators (KRIs), Parameters with Quality Tolerance Limits (PQTLs) and other trial specific data analytics tailored to the individual protocol according to the trial Risk Assessment and Mitigation PlanReview and approve trial specific RBQM set-up documentation for adherence with RBQM frameworkAttend study team meetings as neededSupport the development and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the studySupport presentations and training of internal and external team membersEnsure that knowledge from one trial/program is applied in other trials/programs and offer assistance to team members to create an effective and supportive working environmentEnsure lessons learned are documented and shared with the rest of the organization to facilitate cross-study and cross-organization learningProactively manage progress of agreed RBQM activities with selected RBM vendorSuperuser of RBQM functionalityMaintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processesFacilitate the adoption and understanding of RBQM across project teamsLead/support implementation of RBQM and continuous training to Genmab employees and vendors as applicableLead/support working groups in initiatives for RBQM and central monitoring or related process/system improvementSupport the update and maintenance of a CD/P risk library, incl.
PQTLs/KRIsRequirementsFor this role we need you, who have previous experience in working with RBQM adoption, including identification of critical data and process, associated risks and monitoring strategies.
You will have a key role in bringing together all the relevant skill areas involved in monitoring activities. You are motivated to work in a company culture with an entrepreneurial spirit along with highly competent colleagues. Genmab experiences rapid growth and we are in the starting phase of building the future Risk Based Quality Management.Hence, it is imperative that you thrive in a changing environment where you have great opportunities to influence the path and outcome.
You recognize yourself in following descriptions:
You have a minimum of 4 years of experience from biotech or pharma companies You have experience in planning and executing Risk Based Quality Management (RBQM) activities in collaboration with Clinical Trial Team (CTT)
You have been guiding CTT in identification of critical data and processes, performing risk assessment and mitigation workshops, defining appropriate monitoring strategies, and developing monitoring plansYou have been performing centralized monitoring of Key Risk Indicators to identify trends and communicate the surfacing signals to CTTYou have experience in collaboration with clinical CRO in relation to planning and overseeing monitoring strategiesYou understand the processes within trial management or data managementYou either have a good understanding of oncology or a strong willingness to learn about oncology enabling you to identify clinical data and processesYou thrive with planning and organizational tasksYou work in an analytical manner and can interpret and present dataYou understand clinical development/trial conduct, including GCP, ICH E6 (R2), ICH E8 (R1)You have good Communication skills and can communicate scientific communication in a clear and concise mannerYou are comfortable solving problems and making decisionsYou are detail oriented and have a quality mindsetYou enjoy working with process developmentFor US based candidates, the proposed salary band for this position is as follows:
$35,625.00$59,375.00The 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 YouYou are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do.
You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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 soLocationsGenmab 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-YourOur 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 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 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.