Clinical Scientist Director – Late Development Oncology
Hace 2 días
Tarragona, Cataluña, España
Amgen
Jornada completa
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Overview In this role you drive late-phase oncology development by turning scientific strategy into executable trials. You will act as a clinical and scientific expert, overseeing protocol execution, data quality, and cross-functional collaboration to align with regulatory and Amgen standards. You’ll monitor subject-level data to spot trends and risks, and guide CROs and collaborators to deliver high-quality, decision-ready data. Your work directly supports translating research into impactful cancer therapies, contributing to Amgen’s patient-focused mission. Compensaciones / Beneficios
* comprehensive health and welfare plans
* Retirement and Savings Plan with company contributions
* stock-based long-term incentives
* bonus program
* flexible spending accounts
* award-winning time-off plans Responsabilidades
* Provide clinical and scientific oversight for late-phase oncology trials and protocol execution
* Ensure data quality and integrity across the trial lifecycle
* Collaborate with cross-functional teams to translate strategy into study concepts, protocols, and governance
* Monitor subject-level data to identify trends, risks, and issues
* Lead data reviews and interpretation to support regulatory-ready submissions and routine clinical decisions
* Manage external partners (CROs, consultants) and internal stakeholders to ensure timely delivery of key projects
* Contribute to medical monitoring and overall trial data interpretation for safety and efficacy
* Support study data readouts and completion activities (data cleaning, lock, extraction) and drafting regulatory responses Requisitos principales
* Doctorate, 4+ years in life sciences/healthcare OR Master’s, 7+ years OR Bachelor’s, 9+ years in life sciences/healthcare
* Experience in pharmaceutical clinical drug development, preferably late-phase oncology
* Strong written and oral communication skills for leadership committees
* Experience designing and monitoring oncology clinical trials compliant with GCP and regulatory requirements
* Experience data readouts, data cleaning, database lock, and data extraction
* Ability to author high-level regulatory submission documents and contribute to scientific publications
* Experience with clinical data analysis tools (e.g., Spotfire)
* strong communication & presentation skills
* problem-solving and proactive issue management
* cross-functional collaboration
* designing and monitoring oncology trials
* data review and interpretation of clinical trial results
* compliance with GCP and regulatory requirements
* comprehensive health and welfare plans
* Retirement and Savings Plan with company contributions
* stock-based long-term incentives
* bonus program
* flexible spending accounts
* award-winning time-off plans Responsabilidades
* Provide clinical and scientific oversight for late-phase oncology trials and protocol execution
* Ensure data quality and integrity across the trial lifecycle
* Collaborate with cross-functional teams to translate strategy into study concepts, protocols, and governance
* Monitor subject-level data to identify trends, risks, and issues
* Lead data reviews and interpretation to support regulatory-ready submissions and routine clinical decisions
* Manage external partners (CROs, consultants) and internal stakeholders to ensure timely delivery of key projects
* Contribute to medical monitoring and overall trial data interpretation for safety and efficacy
* Support study data readouts and completion activities (data cleaning, lock, extraction) and drafting regulatory responses Requisitos principales
* Doctorate, 4+ years in life sciences/healthcare OR Master’s, 7+ years OR Bachelor’s, 9+ years in life sciences/healthcare
* Experience in pharmaceutical clinical drug development, preferably late-phase oncology
* Strong written and oral communication skills for leadership committees
* Experience designing and monitoring oncology clinical trials compliant with GCP and regulatory requirements
* Experience data readouts, data cleaning, database lock, and data extraction
* Ability to author high-level regulatory submission documents and contribute to scientific publications
* Experience with clinical data analysis tools (e.g., Spotfire)
* strong communication & presentation skills
* problem-solving and proactive issue management
* cross-functional collaboration
* designing and monitoring oncology trials
* data review and interpretation of clinical trial results
* compliance with GCP and regulatory requirements