Global Oncology Clinical Research Lead

Genmab; Princeton (NJ); Hybrid; USD 144,000 - 216,000; Full time

Benefits offered by this job

401(k) Plan: 100% match on the first 6

Health benefits

Voluntary plans

Paid time off

Backup care support

Tuition reimbursement

Lifestyle Spending Account

Commuter benefits

Job summary

Genmab in Princeton, NJ, is seeking a Senior Clinical Research Scientist to drive the global development strategy and lead clinical trials across therapeutic areas. You will collaborate with the Medical Director and cross-functional teams to deliver high-quality data and regulatory documents for registration and commercialization.

The role is hybrid in Princeton, with travel as needed. A PhD/PharmD/MS-equivalent is required, plus 6+ years in clinical research and 3+ years in drug development,

Qualifications

• 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.

Responsibilities

• Lead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds.
• Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted).
• Contributes 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, contributes to the development of clinical and regulatory documents, annual safety updates, and registration dossiers to support registration and commercialization of the compound(s).
• Participates in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables.
• Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis.
• Contributes medical input for country/site selection, feasibility assessment and engage in KOL interaction.
• Prepare charters and coordinate internal/external committee meetings including presentation preparation.
• 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

Skills

Excellent communication

Travel flexibility

Education

PhD

Pharm D

MS or equivalent

Job description

Genmab in Princeton, NJ, is seeking a Senior Clinical Research Scientist to drive the global development strategy and lead clinical trials across therapeutic areas. You will collaborate with the Medical Director and cross-functional teams to deliver high-quality data and regulatory documents for registration and commercialization.

The role is hybrid in Princeton, with travel as needed. A PhD/PharmD/MS-equivalent is required, plus 6+ years in clinical research and 3+ years in drug development,