Senior, Clinical Research Scientist
Genmab
7 hours ago
Remote friendly (Plainsboro, NJ)
United States
Clinical Research and Development
Responsibilities:
- Lead, co-lead, or support one or more clinical trial(s) in a therapeutic area for one or more compounds.
- Work closely with the Medical Director and other senior Clinical Research Scientists (as warranted).
- Contribute to program strategy for assigned trials/compounds and participate in development of the clinical development plan (CDP).
- In collaboration with the Medical Director, contribute to clinical and regulatory documents, annual safety updates, and registration dossiers (e.g., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions such as briefing documents, IND, clinical dossiers) to support registration and commercialization.
- Participate in development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for key data management deliverables (e.g., database lock activities).
- Lead 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 (e.g., Dose Escalation Committee, DMC, Steering Committee, Safety Committees), including presentation preparation.
- Participate in development and review of study plans; serve as liaison to project teams and CROs.
- Provide input for publications in coordination with Scientific Communications.
- Contribute to training at Investigator meetings, CRO/CRA training, SIVs (as warranted).
Requirements:
- PhD, Pharm D, MS, or equivalent degree (preferably in medical, biological, pharmaceutical science, or related discipline).
- Minimum 6 years of experience in clinical research, with at least 3+ years of drug development experience.
- Prior oncology drug development experience.
- Solid Tumor experience (preferred).
- Late Phase experience (preferred).
- Proven skills working in a project-oriented, matrixed team environment.
- Excellent oral, written, and interpersonal communication skills.
- Ability to travel as needed.
- Lead, co-lead, or support one or more clinical trial(s) in a therapeutic area for one or more compounds.
- Work closely with the Medical Director and other senior Clinical Research Scientists (as warranted).
- Contribute to program strategy for assigned trials/compounds and participate in development of the clinical development plan (CDP).
- In collaboration with the Medical Director, contribute to clinical and regulatory documents, annual safety updates, and registration dossiers (e.g., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions such as briefing documents, IND, clinical dossiers) to support registration and commercialization.
- Participate in development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for key data management deliverables (e.g., database lock activities).
- Lead 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 (e.g., Dose Escalation Committee, DMC, Steering Committee, Safety Committees), including presentation preparation.
- Participate in development and review of study plans; serve as liaison to project teams and CROs.
- Provide input for publications in coordination with Scientific Communications.
- Contribute to training at Investigator meetings, CRO/CRA training, SIVs (as warranted).
Requirements:
- PhD, Pharm D, MS, or equivalent degree (preferably in medical, biological, pharmaceutical science, or related discipline).
- Minimum 6 years of experience in clinical research, with at least 3+ years of drug development experience.
- Prior oncology drug development experience.
- Solid Tumor experience (preferred).
- Late Phase experience (preferred).
- Proven skills working in a project-oriented, matrixed team environment.
- Excellent oral, written, and interpersonal communication skills.
- Ability to travel as needed.