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HOW MIGHT YOU DEFY IMAGINATION?If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.Strategic Planning & Operations Senior ManagerLiveWhat you will doLet’s do this. Let’s change the world. Increasing demand for observational research (now commonly referred to as real-world evidence [RWE] from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle. CfOR scientists partner with internal stakeholders and industry experts to design, conduct, interpret, and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines.In this vital role, you will focus on ensuring that Observational Research (OR) processes at Amgen are consistent with or exceed industry standards. This includes managing the Observational Research Review Group (ORRG) templates and processes, development and ownership of OR SOPs, training, change management, inspection readiness, deviation reporting and investigation, and resource and portfolio assessments.Key Responsibilities include:
CfOR point of contact and advisor for Amgen study-level Compliance– Manages and oversees inspection readiness preparation, inspection preparation, non-interventional Observational Research deviation management, and implementing robust Corrective Actions/Preventative Actions in collaboration with Compliance
Conducts root cause analyses to ensure a deep understanding of challenges and opportunities
Develop an understanding of the changing regulatory landscape for observational studies to ensure compliance including adhering to expectations set by IRB, ICH-GCP, local Heath Authorities, Ethics Committees, and ENCePP.
Partners with the Observational Research Review Group (ORRG) chair to establish clear guidance for non-interventional OR studies including streamlining evaluation, charter revisions/maintenance, metrics accuracy and reporting, and audit readiness
Reviews and updates specific Standard Operating Procedures and other controlled documents as needed to ensure best practice and compliance; incorporates necessary revisions to processes; serves as the point of contact for the department to assess changes needed and answer queries related to the processes detailed in the documents
Works with epidemiology team and data and analytics teams to develop guidance documents and central resources for critical/complicated/infrequent processes to ensure compliance and efficiencies.
Leads or contributes to organizational capability build and transformational/process improvement initiatives, ensuring the long-term sustainability of improvements. (including RIM, eTMF, requirements for PASS studies, requirements for Observational Research Study Reports, Quality Control process for regulatory documents, etc.)
Wears multiple hats as needed – Support the Operations Head, lead special projects, conduct required analysis, and create deliverables as needed.
Identifies value measures, trade-offs, risks, and gaps in improvement strategy
Brings the right functions together at the right time and integrates cross-functional input to facilitate end–to–end observational research development.
Supports idea generation in functions to ensure a steady stream of ongoing projects and pending ideas to align with short and long-term targets
Builds and maintains positive collaborations; communicating, seeking advice, and facilitating critical business decisions.
WinWhat we expect of youWe are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a program leader with these qualifications.Basic Qualifications:Doctorate degree and 2 years of research and program management experienceOrMaster’s degree and 4 years of research and program management experienceOrBachelor’s degree and 6 years of relative experienceOrAssociate’s degree and 10 years of relative experienceOrHigh school diploma / GED and 12 years of relative experiencePreferred Qualifications:
Demonstrated self-starter, ability to work under limited supervision and coordinate multiple projects in a detail-oriented and regulated environment
Knowledge of Observational research and associated processes
Experience with critically evaluating processes and establishing innovative and creative solutions
Experience facilitating discussions and promoting collaboration across multiple parties
Perseverance and Problem Solving Skills
Excellent written, analytical, and oral communication skills. Able to clearly and effectively present information
Clinical Study Management experience
Strong project management skills, lead and manage projects from concept to completion in a matrix and at times ambiguous environment with demonstrated success
High proficiency with Microsoft Office suite, Smartsheet, and/or Observational research databases.
ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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
Apply now!for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.iation reporting and investigation and resource and portfolio assessments.Key Responsibilities include:
CfOR point of contact and advisor for Amgen study-level Compliance– Manages and oversees inspection readiness preparation, inspection preparation, non-interventional Observational Research deviation management, and implementing robust Corrective Actions/Preventative Actions in collaboration with Compliance
Conducts root cause analyses to ensure deep understanding of challenges and opportunities
Develops an understanding of the changing regulatory landscape for observational studies to ensure compliance including adhering to expectations set by IRB, ICH-GCP, local Heath Authorities, Ethics Committees and ENCePP.
Partners with Observational Research Review Group (ORRG) chair to establish clear guidance for non-interventional OR studies including streamlining evaluation, charter revisions/maintenance, metrics accuracy and reporting, and audit readiness
Reviews and updates specific Standard Operating Procedures and other controlled documents as needed to ensure best practice and compliance; incorporate necessary revisions to processes; serve as the point of contact for the department to assess changes needed and answer queries related to the processes detailed in the documents
Works with epidemiology team and data and analytics teams to develop guidance documents and central resource for critical/complicated/infrequent processes to ensure compliance and efficiencies.
Leads or contributes to organizational capability build and transformational/process improvement initiatives, ensuring and long-term sustainability of improvements. (including RIM, eTMF, requirements for PASS studies, requirements for Observational Research Study Reports, Quality Control process for regulatory documents, etc.)
Wears multiple hats as needed – Support the Operations Head, lead special projects, conduct required analysis and create deliverables as needed.
Identifies value measures, trade-offs, risks, and gaps in improvement strategy
Brings the right functions together at the right time and integrate cross-functional input to facilitate end–to-end observational research development.
Supports idea generation in functions to ensure a steady stream of ongoing projects and pending ideas to align with short and long-term targets
Builds and maintains positive collaborations; communicating, seeking advice, and facilitating critical business decisions.
WinWhat we expect of youWe are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a program leader with these qualifications.Basic Qualifications
Doctorate degree and 2 years of research and program management experience Or
Master’s degree and 6 years of research and program management experience Or
Bachelor’s degree and 8 years of relative experience Or
Associate’s degree and 10 years of relative experience Or
High school diploma / GED and 12 years of relative experience
Preferred Qualifications
Demonstrated self-starter, ability to work under limited supervision and coordinate multiple projects in a detail oriented and regulated environment
Knowledge of Observational research and associated processes
Experience with critically evaluating process and establishing innovative and creative solutions
Experience facilitating discussions and promoting collaboration across multiple parties
Perseverance and Problem Solving Skills
Excellent written, analytical and oral communication skills. Able to clearly and effectively present information
Clinical Study Management experience
Strong project management skills, lead and manage projects from concept to completion in a matrix and at times ambiguous environment with demonstrated success
High proficiency with Microsoft Office suite, Smartsheet and/or Observational research databases.
