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.
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Support the design, start-up, and execution of global clinical trials, ensuring adherence to protocol, regulatory requirements, and data integrity standards.
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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.
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Collaborate with cross-functional teams to support endpoint strategy, event adjudication processes, and safety monitoring.
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Participate in development and oversight of endpoint adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.
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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.
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Conduct ongoing clinical data review and signal detection, supporting identification and resolution of safety and data quality issues across global trial sites.
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Support preparation and interpretation of interim analyses, database lock activities, and top-line data readouts.
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Assist Development Lead and Clinical Scientist Director with medical monitoring activities and oversight of CROs, vendors, and adjudication committees.
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Collaborate with clinical operations, biostatistics, safety, regulatory, and medical affairs teams to ensure successful delivery of clinical studies across relevant indications and endpoint strategies.
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Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.
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Identify operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 3 years of life sciences/healthcare experience
OR
Master’s degree and 5 years of life sciences/healthcare experience
OR
Bachelor’s degree and 7 years of life sciences/healthcare experience
Preferred Qualifications:
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3 years of pharmaceutical clinical drug development experience, including experience supporting late-stage, global clinical trials.
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Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
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Industry or academic experience in a relevant therapeutic area and/or clinical trials; experience in large global studies preferred.
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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
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Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
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Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, endpoint validation, and generation of analysis outputs to support topline and final results.
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Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
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Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
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Experience in clinical data review and analysis tools such as Spotfire, listings review platforms, or other data visualization and analysis tools.
