Associate Director, Clinical Scientist – Global Trials

amgen; España; Presencial; EUR 90.787 - 122.830; Jornada completa

Descripción de la vacante

AMGEN is seeking a Clinical Scientist Associate Director to lead the design, execution, and oversight of global late-stage clinical studies. You will contribute to protocol development, medical monitoring, and data review to deliver decision-ready data for regulatory submissions.

You will collaborate with cross-functional teams to support endpoint strategy, safety monitoring, and data management, while guiding CROs and vendors. Strong communication and regulatory knowledge are essential.

Formación

• Doctorate degree with 3 years of life sciences/healthcare experience or Master’s with 5 years or Bachelor’s with 7 years of life sciences experience.

Responsabilidades

• Support design, startup, and execution of global clinical trials with adherence to protocol and regulatory requirements.
• Contribute to protocol development, SAPs, investigator brochures, and regulatory documents focusing on endpoints and safety.
• Collaborate with cross-functional teams to support endpoint strategy, adjudication processes, and safety monitoring.
• Develop and oversee endpoint adjudication charters, safety monitoring plans, and DMC interactions.
• Provide clinical input into data management plans, CRF design, and data review focusing on endpoints and safety/biomarker outcomes.
• Perform ongoing clinical data review and signal detection across global sites to identify safety/data quality issues.
• Assist in interpretation of interim analyses, database locks, and topline data readouts.
• Support medical monitoring activities and oversee CROs/vendors/adjudication committees.
• Work with clinical operations, biostatistics, safety, regulatory, and medical affairs to ensure successful study delivery.
• Contribute to clinical study reports, regulatory submissions, publications, and presentations.
• Identify operational or scientific risks and implement mitigation strategies across teams.

Conocimientos

Clinical research

Medical monitoring

Communication skills

Cross-functional collab

Data interpretation

Educación

Doctorate degree

Master’s degree

Bachelor’s degree

Descripción del empleo

AMGEN is seeking a Clinical Scientist Associate Director to lead the design, execution, and oversight of global late-stage clinical studies. You will contribute to protocol development, medical monitoring, and data review to deliver decision-ready data for regulatory submissions.

You will collaborate with cross-functional teams to support endpoint strategy, safety monitoring, and data management, while guiding CROs and vendors. Strong communication and regulatory knowledge are essential.