Executive Director Clinical Program Operations
2 months ago
HOW MIGHT YOU DEFY IMAGINATION?
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.
EXECUTIVE DIRECTOR CLINICAL PROGRAM OPERATIONS GENERAL MEDICINE
LIVE
What you will do
As a part of the Clinical Program Operations Senior Leadership Team, as the Executive Director, you will serve as the primary point of contact for clinical trial execution within General medicine TA and the Observational Research (OR) and Non Amgen Sponsored Clinical Research (NASCR) teams, responsible for ensuring consistency in clinical trial execution across Clinical Program Operations (CPO).
Responsibilities
Serve as the primary point of contact for clinical trial execution for Late Development programs
Ensure operational efficiency and compliance with R&D Standards and training requirements / inspection readiness
Promote and lead continuous improvement in Clinical Program Operations and throughout Global Development Operations (GDO)
Develop and mentor staff to enhance study management skills & actively promote study management best practices
Clinical Program Operations strategy, planning, risk assessment and mitigation, and overall execution within budget and with quality
Ensure that programs and sub functions ( e.g. NASCR/ OR) are appropriately resourced in alignment with program prioritization.
Manage program-level operational issues and oversight of study team issue escalation
Maintain global business relationships cross-functionally and communicate global status of clinical trial programs to senior management
Represent CPO (and GDO as appropriate) on organizational and/or process improvement initiatives.
Key activities
Manage CPO budget, headcount, hiring, resourcing, and goal setting
Partner with relevant Early / Clinical Development Leads and their senior staff to ensure alignment and achievement of company goals and objectives.
Oversee global clinical research execution activities within CPO therapy area
Ensure Program or Study Operational Preparedness are held for priority programs
Identify issues related to study execution and assist the staff in their resolution
Communicate escalation of study execution issues to management and the relevant Leadership, as appropriate
Ensure subfunctions (e.g NASCR/ OR) are supported and their delivery aligns with portfolio prioritization
Contribute to interpretation of study feasibility and clinical trial placement decisions
Lead global alignment and consistency for CPO
Identify areas for and drive process improvement and standardization across GDO
Mentor and develop departmental staff/establish succession plans, conduct performance management and performance reviews
Contribute to the development of relevant policies, SOPs and associated documents
Identify training/staff development and oversee the implementation of training plans
Remain current and input into Industry best practices
Lead functional insourcing/outsourcing decisions
Lead the development of CPO metrics and reporting
Promote global and innovative working practices
Contribute to broader strategic organizational considerations as a member of both the GDO and Translational Medicine Senior Leadership Teams
Participate in service provider evaluation (as needed) and management
Ensure representation of CPO at Operation/Functional Management teams (OMT/FMT) to identify cross-study issues requiring resolution by the vendor and/or Amgen
WIN
What we expect of you
Qualifications and Knowledge
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Preferred Qualifications
Degree educated - M.D., D.O., PhD, PharmD, Master’s Degree or equivalent
Extensive clinical research/clinical trial experience
Proven experience of directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Extensive experience in life sciences or medically related field, including biopharmaceutical clinical research (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, clinical research vendors (CROs, central labs, imaging vendors, etc.)
Mastery of global regulatory requirements and guidelines for conducting clinical research and safety monitoring/reporting
Clinical knowledge of relevant therapeutic area
Ability to develop and manage departmental budgets
Understanding of resource management and organizational capacity
Experience developing goals and training plans to maximize talent management/career development of clinical research staff
Experience managing projects in a matrix organization
Ability to network and build relationships to maximize organizational function and capabilities
Experience leading organizations through change
Experience working with international teams on multinational programs
Experience with operational efficiency
THRIVE
What you can expect of 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.
lease contact us to request an accommodation.
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.
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