Company
Healthcare
ClinicalScientistAssociateDirector
Neural analysis suggests this role is
optimal for Director candidates.
“Clinical Scientist Associate Director. Skills: Clinical trials, Protocol development, Data review. Support design, start-up, execution of global clinical trials. Ensure adherence to protocol, regulatory requirements, data integrity”
What You'll Achieve.
Delivery of high-quality, decision-ready clinical data
Industry & Context.
Signal detection; Data quality issues; Operational risks; Mitigation strategies
What They're Looking For.
Must Have
Doctorate degree and 3 years life sciences/healthcare experience, Master’s degree and 5 years life sciences/healthcare experience, Bachelor’s degree and 7 years life sciences/healthcare experience
Nice to Have
3 years pharmaceutical clinical drug development experience, Experience supporting late-stage, global clinical trials, Contributed to clinical trial process improvements, Industry or academic experience in relevant therapeutic area, Clinical experience in large global studies, Experience supporting design, monitoring, implementation of clinical trials, Compliance with Good Clinical Practice standards, Working knowledge of study data readout activities, Experience contributing to regulatory submission documents, Supporting clinical regulatory responses for health authority interactions, Contributing author on scientific publications, Data presentations for internal forums or scientific conferences, Experience in clinical data review and analysis tools
What You'll Do.
execution of global clinical trials
Ensure adherence to protocol
regulatory requirements
Contribute to development of clinical protocols
Contribute to development of statistical analysis plans
Contribute to development of investigator brochures
Contribute to development of regulatory documents
Focus on study endpoints
key efficacy outcomes
Collaborate with cross-functional teams
Support endpoint strategy
Support event adjudication processes
Support safety monitoring
Participate in development of endpoint adjudication charters
Participate in development of safety monitoring plans
Participate in development of Data Monitoring Committee interactions
Provide clinical input into data management plans
Provide clinical input into CRF design
Provide clinical input into clinical data review
Focus on key study endpoints
Focus on imaging or biomarker endpoints
Conduct ongoing clinical data review
Conduct ongoing signal detection
Support identification of safety and data quality issues
Support resolution of safety and data quality issues
Support preparation of interim analyses
Support preparation of database lock activities
Support preparation of top-line data readouts
Assist Development Lead with medical monitoring activities
Assist Clinical Scientist Director with medical monitoring activities
adjudication committees
Collaborate with clinical operations teams
Collaborate with biostatistics teams
Collaborate with safety teams
Collaborate with regulatory teams
Collaborate with medical affairs teams
Ensure successful delivery of clinical studies
Contribute to clinical study reports
Contribute to regulatory submissions
Contribute to scientific publications
Contribute to presentations for internal stakeholders
Contribute to presentations for external stakeholders
Identify operational risks
Identify scientific risks
Proactively implement mitigation strategies
How You'll Work.
Team & Collaboration
Cross-functional teams; Clinical operations teams; Biostatistics teams; Safety teams; Regulatory teams; Medical affairs teams
Communication Scope
Scientific concepts; Clinical data; Written communication; Oral communication
Full Job Description
## **Career Category** Clinical ## ## **Job Description** **What you will do** In this role, the Clinical Scientist Associate Director supports the design, execution, and oversight of clinical trials and other late-phase global clinical studies. The role contributes to protocol development, study execution, medical monitoring support, and clinical data review, ensuring delivery of high-quality, decision-ready clinical data for regulatory submissions and scientific dissemination. * Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards. * Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with focus on study endpoints, key efficacy outcomes, and safety assessments. * Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring. * Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions. * Provide clinical input into data management plans, CRF design, and clinical data review, with focus on key study endpoints, efficacy and safety outcomes, and/or imaging or biomarker endpoints, as applicable. * Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites. * Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts. * Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees. * Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies. * Contribute to clinical
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