Senior Director, Head of Programming job in Princeton
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New Jersey (NJ),
Princeton
| Job Code: | R10360 |
| Employer: | Genmab |
| Category: | Clinical Research |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Princeton |
| Post Date: | 03/23/2024 |
| Description | |
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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 As HoF for Programming, the employee will be part of the Development Operations Leadership Team who defines the overall strategy and identify development areas of the organization and ensures that all teams and employees work toward the same objectives and work as one team. As HoF for the Programming the employee will drive the overall strategy related to programming activities within Genmab in close collaboration with HoF, Biostatistics and HoF, Data Management. The employee is responsible for driving the programming activities across the clinical and regulatory activities related to development programmes/clinical trials and regulatory submissions/filing activities working closely together with relevant stakeholders within CO and across functions. In addition, the employee will support the development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making. The employee will operationally support the Data Management, Statistics, Drug Safety, Medical and Clinical Pharmacology functions across one or more trial and/or programs. The employee is responsible for establishing standard processes, templates and clinical standards to ensure the quality and timelines of regulatory filings and clinical documentation is in accordance with ICH-GCP and other relevant regulatory guidelines/ requirements. The employee will drive the oversight of outsourced programming activities not limited to: selection and management of programmers, ensuring that expectations/responsibilities are clearly defined and described in workorders and manuals. The outsourcing activities will be done in close collaboration with HoF Biostatistics and HoF Data Management. It is expected that the employee act as a role model, proactively engages in department activities, arrange lessons learned to share learnings, leads various initiative, contribute to the overall strategy of the department and proactively contributes to support a global organization. This position builds strong relationship and close communication/interaction with internal e.g. Data management, biostatistics, regulatory affairs, non-clinical, medical and other functional areas as well as external stakeholders e.g. partners, regulatory authorities etc. As HoF for the Programming you need to have extensive experience with NDA, MAA, BLA filings, you need to be systematic, organised, proactive, and accountable with good planning and coordination skills. The employee needs to be analytical with the ability to interpret clinical data and other complex information and effectively communicate expectations and information in a clear and concise manner. As HoF for the Programming the employee may represent Clinical Operations in Project Boards, Global Development Teams and Operational Committee's/Steering Committee's with the partners. As HoF for the Programming group the employee will be responsible for managing, coordinate, develop, supervise and support the employees in the team and ensure that the employees competencies reflect their responsibilities as outlined in their job descriptions. Key Responsibilities: The tasks and department responsibilities are a non exclusive list of high-level tasks:
Other activities:
As Senior Director, Head of Programming, it is expected that the employee:
Requirements - what you must have
Competences:
Where you will work This role can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, the Netherlands and is hybrid. For US based candidates, the proposed salary band for this position is as follows: $206,250.00---$343,750.00 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
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. | |
ref: (R10360) 35 days ago
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