Senior Clinical Research Scientist

Location: Princeton, New Jersey | Type: Contract | Work Model: Remote (offsite)

Responsibilities

• Contribute to the implementation of the global development strategy, leading or co-leading clinical trials in various stages of development, and overseeing all aspects of clinical development working closely with the Medical Director and cross-functional teams to ensure high-quality, timely deliverables
• Develop program strategies for assigned trials/compounds and participate in the creation of the clinical development plan (CDP)
• Collaborate with the Medical Director to develop clinical and regulatory documents, including safety updates, registration dossiers, protocols, ICFs, IBs, study reports, and regulatory submissions to support registration and commercialization
• Assist in the development of case report forms (eCRFs), completion guidelines, and provide scientific support for data management activities such as database lock procedures
• Lead the development of the medical data review plan (MDRP), perform ongoing data reviews, and summarize efficacy and safety data for interpretation and analysis
• Provide medical input for country/site selection, feasibility assessments, and engage with KOLs
• Prepare charters and coordinate internal/external committee meetings, including presentation development for Dose Escalation Committees, DMCs, Steering Committees, and Safety Committees
• Participate in the development and review of study plans, serving as a liaison to project teams and CROs
• Contribute to the development of publications in coordination with Scientific Communications
• Prepare presentations for investigator meetings, CRO/CRA training, and site initiation visits (SIVs) as needed
• Mentor junior Clinical Research Scientists as required

Requirements

• PhD, PharmD, MS, or equivalent degree in medical, biological, pharmaceutical sciences, or related discipline
• Minimum 10 years of experience in clinical research, with at least 3 years in oncology drug development
• Proven experience working in a project-oriented, matrixed team environment
• Ability to work successfully under pressure in a fast-paced environment with tight timelines
• Strong collaboration and communication skills

Pay

$110 per hour

Schedule

9:00 AM to 5:00 PM, 40 hours per week