Clinical Scientist Associate Director – Early Development, Inflammation

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $192.6k - $260.6k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ 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 set up and execution of early phase clinical trials with a focus on data quality. • Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity. • Provide input into and implementation of data management plan, CRF design, and data review oversight. • Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission. • Assists the management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects. • Anticipate and actively manage problems across a broad spectrum of cross-functional teams. • Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents. • Support appropriate training, recruitment, and development requirements for matrix team resources.

🎯 Requirements

• Doctorate degree and 3 years of clinical development experience OR Master’s degree and 5 years of clinical development experience OR Bachelor’s degree and 7 years of clinical development experience OR Associate’s degree and 12 years of clinical development experience OR High school diploma / GED and 14 years of clinical development experience • 3 years of experience in a pharmaceutical industry setting with at least 1 year supporting early or late-phase clinical development within a relevant therapeutic area or disease indication • Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment • 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, and generation of clinical data outputs • 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 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, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.