Job Abstract

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.

Senior Director, Clinical Program Operations, Obesity - US, Remote

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead with global accountability for operational strategy, planning, risk assessment and mitigation, and overall direction of clinical trial programs in Amgen's Obesity organization.

You will also support continuous improvement initiatives in Clinical Program Operations (CPO) and throughout Global Development Operations (GDO)

• Global clinical program operational strategy, planning, risk assessment and mitigation, and implementation
• High-quality delivery of clinical trials on time and within budget
• Leadership 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 required
• 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 TA and Finance
• Managing program-level operational issues and oversight of study team issue concerns
• 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)

• Line management of CPO CPM-SMs / ADs
• Oversee the operational design, planning and direction of all studies for the program
• Oversee the development of timelines and budgets for studies within the program
• Oversee people management, career development, training and succession planning of CPO Senior Managers and Associate Directors
• Oversee structure and engagement of program CPO team
• Input into product Clinical Development Planning (CDP) and 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 awareness of study cost drivers and assumptions as refined throughout KDE and protocol development
• Lead 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 Strategies
• Accountable for study global enrolment plans, revised enrolment plans and accurate global recruitment forecasting
• Support the resolution of cross-functional program issues raised from the study teams and GCST and inform / advance to TA Head and other partners as appropriate
• Leads the GCST to ensure operational consistency and standards across all clinical studies within the program
• Communicate effectively with key partners the program strategy and deliverables
• Contribute to functional goal setting
• Facilitate sharing of best practices, product knowledge and identify areas for process improvement within CPO
• Review 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 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
• Oversee the development of study diversity plans and ensure program actively engaging in DI&B strategies direction

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Doctorate degree and 5 years Clinical Operations experience

OR

Master’s degree and 9 years of Clinical Operations experience

OR

Bachelor’s degree and 11 years of Clinical Operations experience

AND

5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

• Experience of working within obesity or cardio-metabolic disease is paramount
• PhD, PharmD, MSc., B.Sc., or R.N
• Demonstrated experience in life sciences or medically related field including biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
• Previous management experience of direct reports, including management level staff
• Experience 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 / reporting
• Project and Program management including oversight of study deliverables, budgets and timelines
• Time, cost and quality metrics
• Relevant operational expertise
• Understanding of resource management and organizational capacity management
• Experience in developing goals and training plans to enhancing talent and career development of staff
• Experience of managing projects in a matrix organization
• Ability to network and build relationships to enhancing organizational and functional capabilities
• Experience in leading organizations through change

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 $201,628. to $240,546. 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

for 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.

Salary Range