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

LIVE

What you will do

In 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 execution

• High-quality execution 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 execution 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 escalation

• 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)

Key activities:

• Line management of CPO CPM-SMs / ADs

• Oversee the operational design, planning and execution 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 visibility to 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 escalated from the study teams and GCST and inform / escalate to TA Head and other stakeholders as appropriate

• Leads the GCST to ensure operational consistency and standards across all clinical studies within the program

• Communicate effectively with key stakeholders 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 execution of plans

• Represent 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 documents

• Oversee the development of study diversity plans and ensure program actively engaging in DI&B strategies

WIN

What we expect of you

We 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.N

• Proven 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 maximize talent and career development of staff

• Experience of managing projects in a matrix organization

• Ability to network and build relationships to maximize organizational and functional capabilities

• Experience in leading organizations through change

• Experience of working within obesity or cardio-metabolic disease is paramount

THRIVE

What you can expect of us

As 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 organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

LOCATION 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 NOW

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

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 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.