Denmark Job Openings

Genmab
Director, Clinical Research
Ballerup
November 20, 2024
- Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
- Author components and key reviewer 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 (e CRFs), e CRFs 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
- Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
- Prepare, coordinate and/or participate in 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
- Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
- Provide input for the development of publications in coordination with Scientific Communications
- Provides scientific and clinical leadership for Clinical Research Scientists including matrix management responsibilities as applicable
- Ph D, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
- Minimum of 10 years of experience in clinical research with at least 6 or more years of drug development experience
- Prior oncology/hematology drug development experience required
- Proven skills from working in a project oriented matrixed team environment
- Proficiency in leading teams and activities
- Excellent oral, written, and interpersonal (communication) skills
- Ability to travel, as needed
- 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
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