Associate Director Global Clinical Program Management, Obesity
4 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Associate Director Global Clinical Program Management, Obesity - US, Remote
Live
What you will do
Lets do this. Lets change the world. In this vital role you will coordinate and lead all aspects of the operational strategy, planning, risk assessment and mitigation, and overall delivery of Obesity clinical trial programs globally and support continuous improvement initiatives in Clinical Program Operations (CPO) and Global Development Operations (GDO).
Responsibilities:
Line Management of Global Trial Managers (GTM)sSupports Clinical Program Operations (CPO) Director/Snr Director in the following activities (leads activities in the absence of a director level e.g., on smaller programs):Overall delivery of Global clinical program operational strategy, planning, risk assessment and mitigationDeliver high-quality clinical trials on time and within budgetSupports / Leads the Global Clinical Study Team for the allocated program(s)Providing clinical operations leadership and expertise on the Evidence Generation Team (EGT) and in development of the Evidence Generation Plan (EGP)Provide clinical operations leadership and expertise in EGP delivery through the feasibility and study design processDevelopment and oversight of clinical program budgets in collaboration with Therapeutic Area (TA) and FinanceManaging program-level operational issues and oversight of study team issuesMaintaining 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) and Clinical Program Management Director (CPM-D) Key Activities: Lead all aspects of people management, career development, training and succession planning of GTMsSupport and mentor GTMs in people management, career development of respective Local Trial Managers (LTMs)Supports the Global Clinical Program Management Director/ Snr Director in leading all aspects of the planning and delivery of all studies for the program. Accountable for all studies in the program if no director level presentInput into product 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 insight to study cost drivers and assumptions as refined throughout KDE and protocol developmentProvide advice on the operational impact of clinical trial regulations on study assumptions and design - for example In Vitro Diagnostics Regulation (IVDR)Facilitate with protocol developmentSupport and provide advice in the development of the evidence generation plan at EGTLead cross-functional team to build 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 StrategiesSupport in program / study level diversity plansSupport / Accountable for study global enrollment plans revised enrollment plans and accurate global recruitment forecastingSupport the resolution of cross-functional study / program issues raised from the study teams and inform / raise to CPM Director as appropriate advance to TA Head and other partners if no director is presentSupports / Leads program level meetings to ensure operational consistency and standards across all clinical studies within the programCommunicate well with key partners the program strategy and deliverablesSupport functional goal settingFacilitate sharing of optimum practices, product knowledge and identify areas for process improvement within CPOReview vendor evaluation to include identification of outsourcing requirements for study / program and be responsible for management of vendors.Supports and is responsible for 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 delivery of plansRepresent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and delivery. Contribute to development and maintenance of policies, SOPs and associated documentsDepending on the stage of the program, may lead studies (refer to GCTM blueprint for additional information on study management)WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The medical life sciences professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 3 years of life sciences or medically related experience working on clinical trials OR Masters degree and 7 years life sciences or medically related experience working on clinical trials OR Bachelors degree and 9 years life sciences or medically related experience working on clinical trials OR Associates degree and 12 years life sciences or medically related experience working on clinical trials OR High school diploma / GED and 14 years life sciences or medically related experience working on clinical trials In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications:9 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO companyPrevious management experience with direct reportsExperience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)ThriveWhat you can expect of us As 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $161,726. to $207,419. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen 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.-
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