Descripción de la oferta
Overview
In this role you drive late-phase oncology development by turning scientific strategy into executable clinical trials. You lead protocol execution, data quality, and cross-functional collaboration to produce decision-ready data that informs regulatory decisions. You will be a scientific expert across the therapeutic area, guiding investigators, CROs, and internal teams while ensuring compliance with ICH-GCP and Amgen standards. This position offers impact at scale, shaping oncology program outcomes and patient care through rigorous data-driven leadership.
Compensaciones / BeneficiosRetirement and Savings Plan with company contributionsgroup medical, dental and vision coveragelife and disability insuranceflexible spending accountsstock-based long-term incentivesdiscretionary annual bonus
ResponsabilidadesOversee protocol execution and clinical trial integrity across late-phase oncology studiesLead medical data review and ensure data quality to support decision-ready analysesCollaborate with cross-functional teams to translate strategy into study concepts and protocolsProvide clinical input on trial design, governance, and regulatory-aligned documentationManage relationships with collaborators, consultants, and CROs for key projectsMonitor subject-level data for trends, risks, and issues; manage data monitoring plansReview and interpret trial results, ensuring regulatory and protocol adherenceContribute to data readouts and final reporting, including data cleaning and database lockPrepare and present information to leadership and external audiences
Requisitos principalesDoctorate degree with 4+ years in life sciences/healthcare, OR Master’s with 7+ years, OR Bachelor’s with 9+ years5 years of pharmaceutical clinical drug development experience (preferred)Experience in late-phase oncology drug developmentStrong communication and presentation skills for leadership committees (written and oral)Experience designing, monitoring, and implementing oncology clinical trials, compliant with GCP and regulatory requirementsExperience in clinical data analysis and data readout activities (data cleaning, database lock, data extraction)Experience drafting high-level regulatory submission documents and clinical responsesContributing author experience in scientific publications and conference presentationsExperience with data analysis tools (e.g., Spotfire)strong communication skillspresentation abilityleadership and cross-functional collaborationGood Clinical Practice (GCP) and regulatory complianceClinical trial design and governanceData monitoring and data quality assessment
