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Senior Clinical Research Scientist
2 months ago
Position: Clinical Scientist
Company Overview:
Rivus Pharmaceuticals is a privately owned pharmaceutical organization committed to enhancing cardio-metabolic health through the development of controlled metabolic accelerators (CMAs) that target the fundamental metabolic risk factors associated with cardiovascular diseases. We are seeking a dedicated professional to become a vital part of our clinical team.
Role Summary:
The Clinical Scientist will collaborate closely with their supervisor and other members of the interdisciplinary study team to draft and contribute to clinical development documents, while also facilitating the execution of study activities and summarizing data effectively.
Key Responsibilities:
- Provide strategic and tactical input for clinical development
- Develop study protocols
- Review study-related documents including medical monitoring plans, statistical analysis plans, data management plans, eCRF completion guidelines, and data validation manuals
- Train and support study team and CRO personnel on clinical trial aspects
- Accountable to the Clinical Lead for specific trials, including first-line medical monitoring, addressing investigator queries, writing safety narratives, and analyzing safety and efficacy trends
- Maintain and cultivate relationships with key study investigators, and organize steering committees, advisory boards, and data safety monitoring boards as necessary
- Identify risks related to programs, trials, or data, and develop and implement mitigation strategies
- Ensure timely clinical data review and quality of deliverables with input from Medical Monitors, Clinical Trial Management, Biostatistics, and Data Management
- Report clinical trial findings and milestones to supervisor and management
Qualifications:
- Bachelor's degree in a relevant field or nursing required
- Advanced degree (Pharm D, PhD, or N.P.) preferred
- 5-8 years of experience in clinical research or development preferred
- A minimum of 5 years of industry experience in biotechnology or pharmaceuticals
- Strong verbal and written communication skills, along with effective presentation abilities
- Ability to work efficiently in a fast-paced, collaborative environment
- Proven critical thinking and decision-making skills
- Clinical experience with diabetes trials is highly preferred
- Prior experience in large pharmaceutical or biotech companies, particularly in phase II and III trials
- Willingness to travel as needed for important team meetings
- Demonstrated ability to work well with others
- Self-driven and eager to acquire new skills while contributing to the organization's success
- Prepared to engage actively in a start-up environment
Additional Information:
- Compensation will be based on experience
- The company provides a comprehensive benefits package, including an incentive stock option program