Associate Director Global Clinical Program Management (Washington)

Associate Director Global Clinical Program Management

Join to apply for the Associate Director Global Clinical Program Management role at BioSpace

Associate Director Global Clinical Program Management

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Join to apply for the Associate Director Global Clinical Program Management role at BioSpace

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Associate Director Global Clinical Program Management
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)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)
  
  

What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications

• Doctorate degree and 3 years of relevant experience OR
• Masters degree and 5 years of relevant experience OR
• Bachelors degree and 7 years of relevant experience OR
• Associates degree and 12 years of relevant experience OR
• High school diploma / GED and 14 years of relevant experience
  
  

Preferred Qualifications

• 10+ years work experience in life sciences or medically related field, including 8 years of bio-pharmaceutical clinical research experience in early-stage program development obtained working in a biotech, pharmaceutical or CRO company
• Experience at or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)
• 4+ years of direct line management experience
• Previous experience in managing clinical programs
• Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs
  
  

What You Can Expect Of Us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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, Based On Eligibility, Comprising Of 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 That May Include

• A 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
• Flexible work models, including remote and hybrid work arrangements, where possible
  
  

Apply now and make a lasting impact with the Amgen team.
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Application deadline
Amgen anticipates accepting applications until June 13th; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed