Contribute to and/or lead the design of clinical studies in collaboration with the Clinical Research Team
Monitor protocol compliance including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, key safety and efficacy measures
In collaboration with the Medical Lead, review protocol deviations to identify cause and appropriate resolution
Perform regular medical review of individual subject data
Collaboration with the Clinical Research Team on the analysis of study results
Provide scientific support by interpreting safety and efficacy results data
Contribute to database lock, statistical analysis plans, and preparation of Clinical Study Reports
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
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
Coach and guide less experienced Clinical Scientists
Proactively seek out and recommend process improvements
Perform other duties as assigned

Requirements

Minimum of 5 years clinical research experience in the pharmaceutical/biotech industry or academic institution
Prior hematologic malignancy experience strongly preferred
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)
Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
Experience with interacting with medical monitors, development operations and clinical investigators
Patient profile and data listing review experience
Strong analytical, problem-solving, and scientific writing skills
Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel skills
High level of organizational and project management skills
Demonstrated ability to work independently in a matrix environment

Benefits

Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Flexible paid time off
11 paid holidays
Additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Merit-based salary increases
Short incentive plan participation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical researchdrug development processbiostatisticsGCPclinical data analysissafety and efficacy interpretationprotocol compliance monitoringdatabase lockstatistical analysis plansscientific writing

Soft skills

analytical skillsproblem-solving skillsoral communicationwritten communicationorganizational skillsproject management skillscoachingcollaborationprocess improvementindependent work