Associate Medical Science Director - Late Development, Oncology

Role Summary

Associate Medical Science Director - Late Development, Oncology. In this vital role you will contribute to late-phase clinical development of oncology compounds from first-in-human studies through proof of concept. You will collaborate with cross-functional teams to define, design, and deliver late-phase clinical and translational projects, and support protocol development, study startup, data review, monitoring, and analysis.

Responsibilities

• Support set up and execution of late phase clinical trials with a focus on data quality
• Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
• Provide input into and implementation of data management plan, CRF design, and data review oversight
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assists Development Lead and Medical Sciences Director in medical monitoring and management of oncology phase 3 collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
• Support appropriate training, recruitment, and development requirements for matrix team resources

Qualifications

• Required: Doctorate degree and 3 years of clinical research experience
• Required: Master’s degree and 5 years of clinical research experience
• Required: Bachelor’s degree and 7 years of clinical research experience
• Required: Associate’s degree and 12 years of clinical research experience
• Required: High school diploma / GED and 14 years of clinical research experience
• Preferred: 3 years of pharmaceutical clinical drug development experience.
• Preferred: Industry or academic experience in late-phase oncology drug development
• Preferred: Experience cleaning or managing data for a Phase 3 clinical study or regulatory filing
• Preferred: Proven ability to think creatively and develop innovative strategies beyond standard clinical scientist approaches
• Preferred: Demonstrated initiative and problem-solving skills in dynamic, cross-functional team environments
• Preferred: Extensive experience monitoring, cleaning, reviewing clinical trial data and developing medical data review plans
• Preferred: Experience serving on cross functional team and demonstrated ability to collaborate with clinical ops though the conduct of a study
• Preferred: Experience in clinical data analysis such as Spotfire or other data analysis tools