About the position
Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
- Design, execute, and manage complex human tissue studies in collaboration with Amgen teams, external vendors, and CROs.
- Understand and ensure compliance with regulations related to human subject research, specimen collection, and data management.
- Review clinical data and highlight any quality concerns with specimens or associated human clinical data; resolve with CRO and management as needed.
- Provide professional, project-specific guidance to scientific staff.
- Author and review project specific protocols, case report forms (CRFs), SOPs, and biospecimen collection procedures.
- Serve as a point of contact for stakeholders to provide direction, facilitate support, and deliver technical expertise.
- Analyze problems and ensure that improvements are implemented.
Requirements
- Doctorate degree OR Master's degree and 2 years of directly related scientific experience OR Bachelor's degree and 4 years of directly related scientific experience.
- Advanced and proficient understanding and use of technical principles, theories, and concepts to perform an expansive range of work in a role.
- Basic knowledge of related and adjacent disciplinary areas.
Nice-to-haves
- Degree in allied health, biological, or life sciences.
- Demonstrated experience in management of human tissue studies / biospecimen management or clinical trials.
- Ability to think critically, proactively anticipate problems and propose solutions; be results oriented.
- Ability to work effectively/collaboratively across teams, levels of management, across partnerships, use contact network to motivate diverse teams, and enable cross-functional collaborations.
- Familiarity with medical and scientific terminology.
- Previous knowledge or experience in a histology/pathology/laboratory environment; clinical lab experience.
- Possess initiative, independence, flexibility, willingness to learn, ability to embrace challenges, and a strong commitment to quality.
- Excellent interpersonal, verbal, and written communication skills.
- Detail oriented, proactive, ability to work independently and in teams.
- Proficiency with Microsoft Outlook, Excel, Word, Sharepoint, and document management applications.
- Familiarity with databases and data analysis software (StarLIMS, Concentriq, Smartsheet, Miro, Visio, Tableau, etc.).
- Strong organizational, time, and project management skills; ability to prioritize, plan and facilitate meetings, identify and track progress on action items.
- Familiarity with QA/QC/GxP/CAP/CLIA regulations.
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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 and bi-annual company-wide shutdowns.
- Flexible work models, including remote work arrangements, where possible.
