Clinical Sciences Director, Oncology

🔥 23 hours ago

🇺🇸 United States – Remote

💵 $211.2k - $285.7k / year

⏰ Full Time

🔴 Lead

👔 Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Contribute to late-phase clinical development of oncology • Collaborate on teams to define, design, and deliver late-phase clinical results • Support translational projects in the ongoing strategy for drug development • Serve as an internal clinical expert in translational and clinical oncology • Support the medical monitor in clinical trials and assist in resolving issues • Present information internally and externally across cross-functional teams • Identify and manage oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) • Translate clinical strategy into study concept documents, study protocols, and related documents • Ensure protocol integrity and delivery of final protocols and governance approval • Provide clinical input into implementation and delivery of clinical trials • Review and interpret clinical trial data and results • Conduct data quality assessments under a data monitoring plan • Ensure data accuracy, completeness, and adherence to protocols and regulatory requirements

🎯 Requirements

• Doctorate degree and 4 years of life sciences/healthcare experience, OR Master’s degree and 7 years of life sciences/healthcare experience, OR Bachelor’s degree and 9 years of life sciences/healthcare experience • 5 years of pharmaceutical clinical drug development experience preferred • Strong preference for a proven track record of oncology clinical trial process improvement • Industry or academic experience in late-phase oncology drug development • Strong written and oral communication and presentation skills • Experience designing, monitoring, and implementing oncology clinical trials • Experience interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements • Understanding of study data readout activities, including data cleaning, database lock, data extract, and producing data outputs • Experience drafting high-level submission documents for regulatory submissions • Experience authoring clinical regulatory responses for health regulatory interactions • Experience contributing to scientific publications and data presentations at scientific conferences • Experience with clinical data analysis tools such as Spotfire or other data analysis tools • Sponsorship for this role is not guaranteed

🏖️ Benefits

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible • Career development opportunities • Work/life balance • Financial plans with opportunities to save towards retirement or other goals

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