At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
Overview:
The Programming Manager supports 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. Responsibilities in leading the programming activities for a study or leading tasks within a study are in scope.
The Programming Manager will work with other functions including Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational Research, Medical Writing, Project management, and Regulatory.
Responsibilities/tasks – including but not limited to:
- Reviews CRFs for completeness, consistency and/or adherence to standards
- Participates in review of key study documents, including but not limited to SAP and mock shells
- Leads and/or supports development of ADaM specifications based on CDISC and/or Genmab standards
- Supports in-house production & QC of analysis datasets, tables, figures and listings utilizing good programming practices and Genmab standards as appropriate
- Leads and or supports dry run process
- Performs sponsor oversight (acceptance testing) of programming deliverables for outsourced studies
- Supports the establishment and maintenance of Genmab SDTM and ADaM database standards.
- Supports specification and pooling of data across clinical trials within the same project.
- Supports submissions by ensuring that the programming package is consistent with current electronic submission standards and guidelines and meets project team needs.
- Supports resource planning and review of outsourcing budget.
- Ensures proper documentation is kept and filed to eTMF in a timely fashion
- Supports inspections as needed
- Ensures clear communication with cross-functional partners
- Supports data integrity and data security measures
- Supports developing and reviewing standard processes and templates.
- Contributes to knowledge sharing, skill building and good collaboration with stakeholders and colleagues with a mindset of continuous improvement
- Contributes to process improvements
- Maintains up-to-date knowledge and competencies within relevant therapeutic, technical, and professional areas with a mindset of continued learning
- Leads and or supports lessons learned sessions
- Maintains up-to-date knowledge on relevant regulatory guidelines/requirements
- Participates and represent programming in teams and meetings
Qualifications:
- Minimum BSc. or equivalent qualifications
- Oncology experience a plus
- R experience a plus
- Has experience with the SAS software package
- Has experience working in a global context
- Proficient in both written and spoken English
- At least 3-4 years of experience within the pharmaceutical industry
For US based candidates, the proposed salary band for this position is as follows:
$112,960.00---$169,440.00
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.
Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.
About You
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You are genuinely passionate about our purpose
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You bring precision and excellence to all that you do
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You believe in our rooted-in-science approach to problem-solving
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You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
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You take pride in enabling the best work of others on the team
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You can grapple with the unknown and be innovative
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You have experience working in a fast-growing, dynamic company (or a strong desire to)
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You work hard and are not afraid to have a little fun while you do so!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
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 Job Applicant Privacy Notice (genmab.com).
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.
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