Senior Clinical Research Scientist
5 hours ago
We are seeking a highly skilled Senior Clinical Research Scientist to join our Medical Department. As a key member of our team, you will contribute to the implementation of our 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.
Key Responsibilities- Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds
- Work closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted)
- Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
- In collaboration with the Medical Director, contribute 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)
- Participate 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)
- Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
- Contribute medical input for country/site selection, feasibility assessment and engage in KOL interaction
- Prepare charters and coordinate internal/external committee meetings including presentation preparation (ie, Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
- Participate in the development and review of study plans and serve as a liaison to project teams and CROs
- Provide input for the development of publications in coordination with Scientific Communications
- Contribute to training at Investigator meetings, CRO/CRA training, SIVs as warranted
- PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
- Minimum of 6 years of experience in clinical research with at least 3 or more years of drug development experience
- Prior oncology/hematology drug development experience is a plus
- Proven skills from working in a project oriented matrixed team environment
- Excellent oral, written and interpersonal (communication) skills
- Ability to travel, as needed
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.
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.
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