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.
This position contributes to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. This may include clinical trial implementation, and oversight of all aspects of clinical development working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables.
Responsibilities
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Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds.
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Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted)
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Contributes to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
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In collaboration with the Medical Director, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] to support registration and commercialization of the compound(s)
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Participates in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities).
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Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
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Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction
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Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
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Participate in the development and review of study plans and serve as a liaison to project teams and CROs
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Provide input for the development of publications in coordination with Scientific Communications
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Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted
Requirements
Moreover, you meet the following professional requirements:
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PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
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Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience
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Prior oncology/hematology drug development experience is a plus
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Proven skills from working in a project oriented matrixed team environment
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Excellent oral, written and interpersonal (communication) skills
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Ability to travel, as needed
For US based candidates, the proposed salary band for this position is as follows:
$114,375.00-$190,625.00
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
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You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
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You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
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You are a generous collaborator who can work in teams with diverse backgrounds
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You are determined to do and be your best and take pride in enabling the best work of others on the team
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You are not afraid to 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 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
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
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
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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
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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.