Dir Global Clinical Program Mgt

Career Category

Job Description

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

Doctorate degree and 4 years of Global Clinical Program Management experience

OR

Master’s degree and 7 years of  Global Clinical Program Management experience

OR

Bachelor’s degree and 9 years of Global Clinical Program Management experience

Preferred experience

• 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.)
• 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

For US based candidates:

Basic qualifications:

• Doctorate degree and 6 years of Clinical Program Management experience OR
• Master's degree and 8 years of Clinical Program Management experience OR
• Bachelor's degree and 12 years of Clinical Program Management experience

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.

• Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
• 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

Salary Range