Clinical Scientist Associate Director

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

Career Category

Clinical

Job 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.

Salary Range

90,787.65EUR-122,830.35EUR