Senior Manager, Clinical Research Pharmacy Services

September 17

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Amgen

WebsiteLinkedInAll Job Openings

Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• In this vital role you will be responsible for supporting Amgen’s diverse portfolio of Investigational Products • Provide guidance and support to internal groups and clinical sites on clinical trial preparation and administration methods. • Drive and contribute to continuous process improvement relating to Investigational Product. • Monitoring dosing deviation/pharmacy trends and risk indicators. • Advising and supporting key partners to ensure IP Management practices are followed at global sites in line with GCP, ensuring patient safety and data integrity. • Identifying and managing Risk for IP management related activities within individual Clinical Trial design and execution as well as across programs and processes.

Requirements

• Basic Qualifications: Doctorate degree and 2 years of experience • OR Master’s degree and 6 years of experience • OR Bachelor’s degree and 8 years of experience • OR Associate’s degree and 10 years of experience • OR High school diploma / GED and 12 years of experience • Preferred Qualifications: PharmD or equivalent degree • 9 years work experience in life sciences or medically related field, including 6 years biopharmaceutical clinical research experience working on clinical trials at a biotech or pharmaceutical company • Practical experience in a clinical research setting working on complex clinical programs in a pharmacy at an investigational site • Experience with drug formulations and sterile product compounding • Strong interactions or work experience in a biopharmaceutical compliance department • 2 years experience in a project leadership role and/or experience in leading when creating new or developing existing services • 2 years management or leadership experience • Pro-active problem identification and resolution experience • Knowledge Familiarity with advanced concepts of clinical research • Extensive knowledge of ICH/GCP regulations and guidelines • Strong knowledge of clinical trial operations • Computer and system operation skills • Relevant therapeutic area education and training • Detailed understanding of customer service • Demonstrated ability to anticipate and resolve problems • Ability to write and present clearly using scientific and clinical issues terminology • Competencies Demonstrated ability to work independently with minimal supervision • Results oriented and goal driven • Exceptional oral and written communication skills • Ability to organize, interpret and communicate department information both cross-functionally and to local senior management • Excellent organizational and planning skills • Ability to identify and resolve complex problems

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 • 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