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 study reports, regulatory submissions, scientific publications, and presentations for internal and external stakeholders.
+ 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:**
+ 3 years of pharmaceutical clinical drug development experience, including experience supporting late-stage, global clinical trials.
+ Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
+ Industry or academic experience in a relevant therapeutic area and/or clinical trials; experience in large global studies preferred.
+ 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
+ Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
+ 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.
+ Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
+ Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
+ Experience in clinical data review and analysis tools such as Spotfire, listings review platforms, or other data visualization and analysis tools.
