Clinical Research Scientist
3 months ago
The Role
This position may serve in a lead or co-lead role in the implementation of a clinical trial(s) within a program in alignment with the global development strategy. Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist as indicated for ongoing clinical trial-related activities to provide high-quality and timely deliverables.
Responsibilities
- Lead or co-lead a less-complex clinical trial(s) within a program.
- Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist
- Assists to execute the clinical trial in alignment with the clinical development plan (CDP)
- Assists with the development of a trial protocol and to other study-related and regulatory documents
- Assists 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).
- Contribute to the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
- Participates in country/site selection, feasibility assessment and engage in KOL interaction
- Assists in the development of charters and provide support to coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, Adjudication and Safety Committees)
- Assists in the development and review of study plans and serve as a liaison to project teams and CROs
- Assists to prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
Requirements
- PhD, Pharm D, MS or equivalent degree preferably within the medical biological, pharmaceutical science or related discipline
- Clinical research experience preferred.
- Prior oncology/hematology drug development experience is a plus
- Ability to work in a project oriented matrixed team environment
- Excellent oral, written, and interpersonal (communication) skills
- Ability to travel to as needed
For US based candidates, the proposed salary band for this position is as follows:
$95.,00---$.,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 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.
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