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Job Information
Amgen Associate Director Global Clinical Program Management, Obesity - US, Remote in Washington D.C., District Of Columbia
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.
Associate Director Global Clinical Program Management, Obesity - US, Remote
Live
What you will do
Let’s do this. Let’s 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)s
Supports 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 mitigation
Deliver high-quality clinical trials on time and within budget
Supports / 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 process
Development and oversight of clinical program budgets in collaboration with Therapeutic Area (TA) and Finance
Managing program-level operational issues and oversight of study team issues
Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management
Representing CPO on process improvement initiatives
Support 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 GTMs
Support 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 present
Input into product evidence generation plans
Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers
Contribute operational expertise throughout Study design coordinating cross functional input on a continuous basis
Provide advice on development of Key Design Elements (KDE) prior to Governance Body review
Provide insight to study cost drivers and assumptions as refined throughout KDE and protocol development
Provide advice on the operational impact of clinical trial regulations on study assumptions and design - for example In Vitro Diagnostics Regulation (IVDR)
Facilitate with protocol development
Support and provide advice in the development of the evidence generation plan at EGT
Lead 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 Strategies
Support in program / study level diversity plans
Support / Accountable for study global enrollment plans revised enrollment plans and accurate global recruitment forecasting
Support 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 present
Supports / Leads program level meetings to ensure operational consistency and standards across all clinical studies within the program
Communicate well with key partners the program strategy and deliverables
Support functional goal setting
Facilitate sharing of optimum practices, product knowledge and identify areas for process improvement within CPO
Review 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 program
Lead planning for regulatory agency inspection readiness activities (e.g. TMF review) and ensure delivery of plans
Represent 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 documents
Depending on the stage of the program, may lead studies (refer to GCTM blueprint for additional information on study management)
Win
What 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
Master’s degree and 7 years life sciences or medically related experience working on clinical trials
OR
Bachelor’s degree and 9 years life sciences or medically related experience working on clinical trials
OR
Associate’s 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 company
Previous management experience with direct reports
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Thrive
What 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 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 imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
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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