Senior Director, Clinical Program Operations

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. Join us.SENIOR DIRECTOR, CLINICAL PROGRAM OPERATIONS LIVEWhat you will doIn this vital role you will lead and have global accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs in Amgen's Obesity organisation.You will also support continuous improvement initiatives in Clinical Program Operations (CPO) and throughout Global Development Operations (GDO)Responsibilities:Global clinical program operational strategy, planning, risk assessment and mitigation, and overall executionHigh-quality execution of clinical trials on time and within budgetLeadership of the Global Clinical Studies Team (GCST) for the allocated program(s)Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan (EGP) and PT as requiredProvide clinical operations leadership and expertise in EGP execution through the feasibility and study design processDevelopment and oversight of clinical program budgets in collaboration with TA and FinanceManaging program-level operational issues and oversight of study team issue escalationMaintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior managementRepresenting CPO on process improvement initiativesSupport CPO resource planning for assigned program(s) in collaboration with Program Resource Management (PRM)Key activities:Line management of CPO CPM-SMs / ADsOversee the operational design, planning and execution of all studies for the programOversee the development of timelines and budgets for studies within the programOversee people management, career development, training and succession planning of CPO Senior Managers and Associate DirectorsOversee structure and engagement of program CPO teamInput into product Clinical Development Planning (CDP) and evidence generation plansInitiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior ManagersContribute operational expertise throughout study design coordinating cross functional input on a continuous basisProvide advice on development of Key Design Elements (KDE) prior to Governance Body reviewProvide visibility to study cost drivers and assumptions as refined throughout KDE and protocol developmentLead cross-functional team to create and periodically review/revise program & study Clinical Trial-Risk Assessment Categorization Tool (CT-RACT)Evaluate if “Patient Voice” techniques should be incorporated on program and design, implement and measure the success of subject Recruitment and Retention StrategiesAccountable for study global enrolment plans, revised enrolment plans and accurate global recruitment forecastingSupport the resolution of cross-functional program issues escalated from the study teams and GCST and inform / escalate to TA Head and other stakeholders as appropriateLeads the GCST to ensure operational consistency and standards across all clinical studies within the programCommunicate effectively with key stakeholders the program strategy and deliverablesContribute to functional goal settingFacilitate sharing of best practices, product knowledge and identify areas for process improvement within CPOReview vendor evaluation to include identification of outsourcing requirements for study / program and oversee management of vendors.Supports and oversees internal audit and inspection activities and contributes to CAPAs globally for the programLead planning for regulatory agency inspection readiness activities (e.g. TMF review) and ensure execution of plansRepresent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution. Contribute to development and maintenance of policies, SOPs and associated documentsOversee the development of study diversity plans and ensure program actively engaging in DI&B strategiesWINWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:Degree educated, PhD, PharmD, MSc., B.Sc., R.NProven experience in life sciences or medically related field including biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO companyPrevious management experience of direct reports, including management level staffExperience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reportingProject and Program management including oversight of study deliverables, budgets and timelinesTime, cost and quality metricsRelevant operational expertiseUnderstanding of resource management and organizational capacity managementExperience in developing goals and training plans to maximize talent and career development of staffExperience of managing projects in a matrix organizationAbility to network and build relationships to maximize organizational and functional capabilitiesExperience in leading organizations through changeExperience of working within obesity or cardio-metabolic disease is paramountTHRIVEWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.Vast opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsLOCATION Ability to work fully remote, or, if situated near an office, the option to work flexibly from home with occasional office presence at our Cambridge or Uxbridge next-generation workspace.APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen 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 a 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 an accommodation.
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