Clinical Scientist Director – Late Development Oncology, Thoracic/GI

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $211.2k - $285.7k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical 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 late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials • Serve as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data • Work collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval • Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results • Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle.

🎯 Requirements

• Doctorate degree and 4 years of clinical development experience OR Master’s degree and 7 years of clinical development experience OR Bachelor’s degree and 9 years of clinical development experience • 5 years of pharmaceutical clinical drug development experience • Strong preference for individuals with proven track record of clinical trial process improvement • Industry or academic experience in late-phase drug development for Oncology • Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral) • Experience with designing, monitoring, and implementing clinical trials for Oncology and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements • Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data • Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions • Serving as a contributing author to scientific publications and data presentations at scientific conferences • Experience in clinical data analysis such as Spotfire or other data analysis tools.

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program • stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.