Senior Clinical Research Scientist

Responsibilities

• Contribute to and/or lead the design of clinical studies in close collaboration with the Clinical Development Team.
• Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, and key safety and efficacy measures.
• In collaboration with the Medical Lead, review protocol deviations to identify cause and appropriate resolution.
• In collaboration with the Medical Lead, perform regular medical review of individual subject data.
• Collaborate with the Clinical Development Team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting.
• Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
• In collaboration with the Clinical Development Team, contribute to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical documents.
• Complete and/or lead other special projects.
• Review and summarize relevant literature.
• Contribute to drafting manuscripts and other publications and presentations.
• Provide support for advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery of presentations.
• Understand the competitive landscape and provide insights on strategic development pathways.
• Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements.
• As appropriate, coach and guide less experienced Clinical Scientists.
• Proactively seek out and recommend process improvements.
• Perform other duties as assigned.

Qualifications

• Minimum of 2-5 years clinical research experience in the pharmaceutical/biotech industry or academic institution (clinical science, clinical operations, medical writing, clinical site staff, etc.).
• BS/MS/PhD in a related life science discipline.
• Comprehensive understanding of the drug development process from Phase 1 to Phase 3.
• Prior oncology drug development or oncology patient care experience preferred.
• Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Experience with interacting with medical monitors, development operations (clinical operations, data management, program management, regulatory affairs, medical writing) and clinical investigators.
• Patient profile and data listing review experience.
• Up to date in new clinical trial designs in oncology.
• Strong analytical, problem-solving, and scientific writing skills.
• Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills.
• High level of organizational and project management skills.
• Demonstrated ability to work independently in a matrix environment.
• Demonstrated ability to prioritize and manage multiple tasks simultaneously.
• Demonstrated ability to influence through collaboration.
• Flexibility to accommodate changes in priorities and project needs.

The base salary hiring range for this position is expected to be $117,000 to $152,000 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate’s relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time and our tuition reimbursement program.