Clinical Scientist:

Scientist, Manager Level

About Us:

Rivus Pharmaceuticals is a privately held pharmaceutical company located in Charlottesville, VA, that is dedicated to improving cardio-metabolic health by developing controlled metabolic accelerators (CMAs) that address the underlying metabolic risk factors for cardiovascular mortality and morbidity. We are looking for a new member to join our clinical team.

Job Description:

The Clinical Scientist will work closely with their supervisor and other members of the cross-functional study team to author and contribute to clinical development documents and facilitate execution of study activities and data summarization.

Duties:

• Clinical development strategic and tactical input
• Protocol development
• Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc.
• Trains and supports study team and CRO personnel regarding clinical aspects of trial
• Accountable to the Clinical Lead for the project for a specific trial for: first-line medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
• Maintains and develops relationship with key study investigators, organizes steering committees, advisory boards, and data safety monitoring boards as required
• Identifies program, trial, or data risks, then creates and implements mitigation strategies
• Responsible, with input from Medical Monitors, Clinical Trial Management Biostatistics and Data Management for timely clinical data review and quality of deliverables
• Reports to supervisor and management on clinical trial findings and milestones

Skills and Qualifications:

• Bachelors or nursing degree required
• Advanced degree (Pharm D, PhD, or N.P.) preferred
• 5-8 years of clinical research/development experience preferred
• Minimum of 5 years of industry experience in biotech or pharma
• Effective communication (verbal & written) and presentation skills are essential
• Must be able to work productively in a fast-paced collaborative environment
• Demonstrated ability for critical thinking and sound decision-making
• Clinical experience with diabetes trials strongly preferred
• Previous big pharma/biotech experience – phase II and III trials
• Ability to travel to Charlottesville, VA on a quarterly basis or as required for important team meetings
• Demonstrated ability to collaborate well with others
• Self-motivated and eager to learn new skills and contribute to the success of the organization
• Willingness to “roll up sleeves” in a start-up environment

Other:

• Compensation commensurate with experience
• Company offers a full suite of benefits including an incentive stock option program