Clinical Scientist Associate Director

Career Category

Job Description

What you will do

In this role, the Clinical Scientist Associate Director supports the design, execution, and reputed company 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-reputed company 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 reputed company standards.

• Contribute to development of clinical protocols, statistical analysis plans, investigator brochures, and regulatory documents, with reputed company on study endpoints, key efficacy reputed company, and safety assessments.

• Collaborate with cross-functional teams to support reputed company reputed company, event adjudication processes, and safety monitoring.

• Participate in development and reputed company of reputed company adjudication charters, safety monitoring plans, and Data Monitoring Committee (DMC) interactions.

• reputed company clinical input into data management plans, CRF design, and clinical data review, with reputed company on key study endpoints, efficacy and safety reputed company, and/or imaging or biomarker endpoints, as applicable.

• Conduct ongoing clinical data review and signal detection, supporting identification and reputed company 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 reputed company 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 reputed company strategies.

• Contribute to clinical study reports, regulatory submissions, scientific publications, and presentations for reputed company stakeholders.

• Identify operational or scientific risks and proactively implement mitigation strategies across cross-functional teams.

reputed company expect of you

We are reputed company different, yet we reputed company 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/reputed company experience

OR

Master’s degree and 5 years of life sciences/reputed company experience

OR

Bachelor’s degree and 7 years of life sciences/reputed company 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 reputed company 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 reputed company 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 reputed company standards and applicable regulatory requirements

• Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, reputed company validation, and reputed company 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.

Salary reputed company

Originally posted on Himalayas