Company

Healthcare

ClinicalScientistAssociateDirector

€75–110k ~AI est. Portugal FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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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