Company
Healthcare
ClinicalScientistAssociateDirector
Neural analysis suggests this role is
optimal for Associate Director candidates.
“Clinical Scientist Associate Director. Skills: Clinical trials, Protocol development, Data review. Support design global clinical trials. Support start-up global clinical trials”
What You'll Achieve.
Delivery high-quality data; Decision-ready clinical data; Support regulatory submissions; Support scientific dissemination
Industry & Context.
Signal detection; Identify safety issues; Identify data quality issues; Risk mitigation
What They're Looking For.
Must Have
Doctorate degree and 3 years life sciences experience, Master's degree and 5 years life sciences experience, Bachelor's degree and 7 years life sciences experience
Nice to Have
3 years pharmaceutical clinical drug development, Contribute to clinical trial process improvements, Industry or academic experience relevant therapeutic area, Clinical experience large global studies, Experience supporting clinical trial design, Experience supporting clinical trial monitoring, Experience supporting clinical trial implementation, Working knowledge study data readout activities, Experience contributing to regulatory submission documents, Supporting clinical regulatory responses, Experience serving contributing author scientific publications, Experience serving data presentations internal forums, Experience serving data presentations scientific conferences, Experience clinical data review analysis tools
What You'll Do.
Support design global clinical trials
Support start-up global clinical trials
Support execution global clinical trials
Contribute development clinical protocols
Contribute development statistical analysis plans
Contribute development investigator brochures
Contribute development regulatory documents
Collaborate cross-functional teams
Support endpoint strategy
Support event adjudication processes
Support safety monitoring
Participate development endpoint adjudication charters
Participate development safety monitoring plans
Participate development Data Monitoring Committee interactions
Provide clinical input data management plans
Provide clinical input CRF design
Provide clinical input clinical data review
Conduct ongoing clinical data review
Conduct ongoing signal detection
Support preparation interim analyses
Support preparation database lock activities
Support preparation top-line data readouts
Assist medical monitoring activities
Assist oversight CROs
Assist oversight vendors
Assist oversight adjudication committees
Collaborate clinical operations
Collaborate biostatistics
Collaborate regulatory
Collaborate medical affairs
Contribute clinical study reports
Contribute regulatory submissions
Contribute scientific publications
Contribute presentations internal stakeholders
Contribute presentations external stakeholders
Identify operational risks
Identify scientific risks
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
Convey scientific concepts; Convey clinical data; Written communication; Oral communication; Scientific publications; Data presentations
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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