Clinical Scientist Associate Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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.

🎯 Requirements

• 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 • 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.