At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
DIRECTOR CLINICAL PROGRAM MANAGEMENT
LIVE
What you will do
As a Director Clinical Program Management, you will be a single point of accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs.
Key responsibilities include:
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 (GCSTs) 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)
Providing clinical operations leadership and expertise in EGP execution through the feasibility and study design process Development and oversight of clinical program budgets including change control 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
Oversee the operational design, planning and execution of all studies for the program
Oversee the development of study timelines and budgets for studies within the program
Oversee people management, career development, training and succession planning of Senior Manager Clinical Program Management
Input into product Global and Regional evidence generation plans (product level)
Contribute operational expertise throughout study design coordinating cross functional input on a continuous basis
Design, implement and measure the success of Subject Recruitment and Retention Strategies
Accountable for study global enrolment baselines, re-baselines and accurate global recruitment forecasting
Contribute to capability assessments for new vendors and participate in vendor qualification assessments
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
Accountable for risk assessment and risk mitigation at a study and program level
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
Participate in vendor evaluation and management, may represent CPO at Operational Management Teams (OMT)
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
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:
Basic Qualifications
Bachelor’s degree or equivalent
Proven experience within Global Clinical Program Management
Project management and planning experience
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.)
Proven experience within:
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
Demonstrable experience of working in agile way with innovative mindset
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:This role will accept applicants from UK and US.
APPLY NOW
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
