Senior Clinical Research Scientist
Genmab
15 days ago
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Role
This position contributes to the implementation of the global development strategy by leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds at various stages of clinical development, including clinical trial implementation and oversight of clinical development activities with the Medical Director and cross-functional teams to deliver high-quality, timely outcomes.
Responsibilities
- Lead/co-lead one or more clinical trials and oversee clinical development aspects.
- Contribute to program strategy and the clinical development plan (CDP).
- Collaborate with the Medical Director to develop clinical/regulatory documents (protocol, ICF, IB, annual safety updates, study reports, regulatory submissions).
- Support eCRFs, eCRF completion guidelines, and data management deliverables (e.g., database lock).
- Develop and execute the medical data review plan (MDRP); review and summarize efficacy/safety data.
- Provide medical input for country/site selection, feasibility, and KOL interaction.
- Prepare charters and coordinate committee meetings (Dose Escalation Committee, DMC, Steering Committee, Safety Committees).
- Develop/review study plans; liaise with project teams and CROs.
- Support publications with Scientific Communications.
- Prepare presentations for investigator meetings and training/SIVs.
- Mentor junior Clinical Research Scientists as needed.
Requirements
- PhD, PharmD, MS, or equivalent (medical/biological/pharmaceutical science or related).
- 6+ years in clinical research; 3+ years drug development experience (preferably oncology).
- Experience in project-oriented matrixed teams; strong GCP knowledge.
- Proven teamwork; can work under pressure with tight timelines.
- Strong clinical research knowledge and communication skills.
Benefits (US)
401(k) match; health/dental/vision; paid time off; 12 weeks discretionary paid parental leave; backup care and wellness support; tuition reimbursement; commuter benefits; Lifestyle Spending Account.
This position contributes to the implementation of the global development strategy by leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds at various stages of clinical development, including clinical trial implementation and oversight of clinical development activities with the Medical Director and cross-functional teams to deliver high-quality, timely outcomes.
Responsibilities
- Lead/co-lead one or more clinical trials and oversee clinical development aspects.
- Contribute to program strategy and the clinical development plan (CDP).
- Collaborate with the Medical Director to develop clinical/regulatory documents (protocol, ICF, IB, annual safety updates, study reports, regulatory submissions).
- Support eCRFs, eCRF completion guidelines, and data management deliverables (e.g., database lock).
- Develop and execute the medical data review plan (MDRP); review and summarize efficacy/safety data.
- Provide medical input for country/site selection, feasibility, and KOL interaction.
- Prepare charters and coordinate committee meetings (Dose Escalation Committee, DMC, Steering Committee, Safety Committees).
- Develop/review study plans; liaise with project teams and CROs.
- Support publications with Scientific Communications.
- Prepare presentations for investigator meetings and training/SIVs.
- Mentor junior Clinical Research Scientists as needed.
Requirements
- PhD, PharmD, MS, or equivalent (medical/biological/pharmaceutical science or related).
- 6+ years in clinical research; 3+ years drug development experience (preferably oncology).
- Experience in project-oriented matrixed teams; strong GCP knowledge.
- Proven teamwork; can work under pressure with tight timelines.
- Strong clinical research knowledge and communication skills.
Benefits (US)
401(k) match; health/dental/vision; paid time off; 12 weeks discretionary paid parental leave; backup care and wellness support; tuition reimbursement; commuter benefits; Lifestyle Spending Account.