Clinical Scientist Lead in Princeton, NJ

Hybrid

Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters

Travel Required

• Domestic and International travel may be required.

 Duties:

• The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
• Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team
• Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials
• Ensures consistency across studies and provide oversight of all clinical studies within assigned area
• May serve as a Clinical Trial Lead or Co-Lead as needed
• May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities
• Serves as a key cross functional collaborator; initial point of escalation cross functions

Key Responsibilities

• Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical development and lifecycle planning
• Lead implementation of assigned clinical development and/or lifecycle plans
• Maintain an advanced understanding of all protocols within assigned Program
• Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members
• Represent Clinical Science Team on the Program Team as appropriate/requested
• Support resourcing and budget planning activities for team
• Review and present data and information to external investigators and internal stakeholders as needed
• Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice
• Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management
• Author/Review abstracts/publications

Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as:

• Evaluation of innovative trial designs
• Protocol and ICF development
• Site-facing activities
• CRA training materials
• Data quality activities; ensure consistent, quality data review across trial teams
• Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities
• Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)

Qualifications & Experience

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)

Experience Requirements:

• 5+ years of experience in clinical science, clinical research, or equivalent
• Experience in driving, managing and collaborating in a team/matrix work environment
• Recognized internally and externally as a Therapeutic Area and Functional expert
• Preferred experience in Neuroscience and/or Psychiatric

Key Competency Requirements:

• Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to plan and manage
• Advanced ability to analyze, interpret, and present data
• Advanced knowledge and skills to support program specific data review, trend identification, data interpretation
• Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements
• Advanced medical writing and presentation skills
• Ability to self-supervise, and act independently to identify/resolve program level issues
• Proficient critical thinking, problem solving, decision making skills
• Effective planning and time management
• Advanced verbal, written and interpersonal skills (communication skills)
• Adaptable and analytical
• Strong presentation skills / leadership presence
• Commitment to Quality
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
• Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
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