10 часов назад
Clinical Scientist Associate Director Early Development Inflammation
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Scientist Associate Director Early Development Inflammation (Clinical Trials): Supporting early-phase inflammation clinical trials from protocol development and study start-up through data review, analysis, and regulatory documentation with an accent on data quality and cross-functional coordination. Focus on implementing data management plans, reviewing clinical readout outputs, coordinating collaborators and CROs, and preparing decision-ready data for leadership and regulatory interactions.
Location: United States; corporate headquarters listed in Thousand Oaks, California, with conditions also listed in Washington, D.C.
Company
Biotechnology organization developing medicines across oncology, inflammation, general medicine, and rare disease.
What you will do
- Support the setup and execution of early-phase inflammation clinical trials, with a focus on data quality.
- Contribute to clinical protocols, Investigator Brochures, study concept documents, and other regulatory materials.
- Provide input into data management plans, CRF design, data review, monitoring, and clinical data analysis.
- Prepare clinical trial data reviews and presentations for internal decisions, external interactions, and regulatory submissions.
- Coordinate collaborators, consultants, CROs, and cross-functional matrix teams while managing study-level issues.
- Support training, recruitment, and development of matrix team resources.
Requirements
- Doctorate degree and 3 years of clinical development experience; or master's degree and 5 years; bachelor's degree and 7 years; associate's degree and 12 years; or high school diploma/GED and 14 years.
- Experience supporting clinical development in a pharmaceutical setting, preferably in early- or late-phase development within a relevant therapeutic area.
- Experience designing, monitoring, and implementing clinical trials in compliance with Good Clinical Practice and applicable regulatory requirements.
- Knowledge of data cleaning, database lock, data extraction, clinical data outputs, and clinical trial readout activities.
- Strong written, oral, communication, and presentation skills for scientific and clinical audiences.
- Experience contributing to regulatory documents, health authority responses, scientific publications, or conference presentations.
Nice to have
- Experience with Spotfire or other clinical data analysis tools.
- Experience improving clinical trial processes within a therapeutic area or study team.
Culture & Benefits
- Collaborative, innovative, and science-based work environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time-off plans and career development opportunities.
- Flexible work models where applicable to the posted work location type.
Hiring process
- Applications remain open until a sufficient number of applications are received or a candidate is selected.
- Sponsorship for this role is not guaranteed.
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