Clinical Scientist Associate Director, Late Development Oncology

Darum lohnt es sich

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 the management of 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.

Requirements • Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience • 3 years of experience in a pharmaceutical industry setting with at least 1 year supporting early or late-phase clinical development within a relevant therapeutic area or disease indication (oncology preferred) • Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment • Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral • Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements • Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs • Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance • Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences • Experience in clinical data analysis such as Spotfire or other data analysis tools.