Senior Clinical Research Scientist

Planet Pharma; Plainsboro Township (NJ); On-site; USD 138,000 - 160,000; Part time

Job summary

Planet Pharma is seeking a Sr. Clinical Research Scientist (Contractor) to join our oncology-focused development program.

You will help implement global development strategies, lead or co-lead trials, and collaborate with the Medical Director to deliver high-quality regulatory and safety documents. You will mentor junior scientists, contribute to trial plans, and support data review activities across clinical phases in a fast-paced environment.

Qualifications

• 10+ years of clinical research experience with oncology drug development
• Experience leading or co-leading multiple clinical trials
• Ability to work in a matrixed team environment and under tight timelines
• Strong communication and collaboration with Medical Director and cross-functional teams

Responsibilities

• Lead or co-lead one or more clinical trials across stages of development
• Contribute to program strategy and development of the clinical development plan
• Develop and review regulatory and safety documents to support registration
• Support data management deliverables and eCRF development and guidelines
• Coordinate committee meetings and presentations with internal/external stakeholders
• Provide input for study plans and liaison with CROs and project teams
• Assist in publications development in coordination with Scientific Communications

Skills

Team leadership

Clinical trial management

Regulatory documentation

Cross-functional collaboration

Data analysis

Education

PhD/PharmD/MS or equivalent in medical/biological/pharmaceutical sciences

Job description

Target Pay Rate: 100-116/hr **salary will be commensurate with experience**

Contractor, Sr. Clinical Research Scientist

Responsibilities

• Contribute to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (e.g. clinical trial implementation), and oversight of all aspects of clinical development working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables
• Contribute 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, contribute to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (i.e., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions) to support registration and commercialization of the compound(s)
• Participate in the development of case report forms (eCRFs), eCRFs 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 charters and coordinate internal/external committee meetings including presentation preparation (i.e., 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
• Provide input for the development of publications in coordination with Scientific Communications
• Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
• Mentor junior level Clinical Research Scientists as required

Qualifications

• PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
• Minimum requirement: 10+ years of experience in clinical research with at least 3 or more years of drug development experience in oncology
• Experience working in a project-oriented matrixed team environment
• Proven experience working in teams
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines