Executive Director, Clinical Program Operations - Thousand Oaks, United States - Amgen

Amgen
Amgen
Verified Company
Thousand Oaks, United States

2 weeks ago

Mark Lane

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Mark Lane

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Description

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
Let's do this. Let's change the world.

In this vital role as Executive Director, you will be a part of the Clinical Program Operations Senior Leadership Team.

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

  • Ensure excellence and consistency in clinical trial execution across Clinical Program Operations
  • Serve as the primary point of contact for clinical trial execution for Early Development programs
  • Partner closely with Global Development Therapy Areas Heads to ensure operational considerations are incorporated into clinical trial design
  • Build and develop a high performing CPO team
  • Champion the delivery of CPO sub functions in supporting clinical trial execution
  • 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)
  • Developing and mentoring 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
  • Ensuring that programs and sub functions (e.g. NASCR/ OR) are appropriately resourced in alignment with program prioritization.
  • All performance management tasks for direct reports, including robust talent management, alignment, and calibration.
  • Managing programlevel operational issues and oversight of study team issue escalation
  • Maintaining global business relationships crossfunctionally and communicating global status of clinical trial programs to senior management
  • Represent CPO (and GDO as appropriate) on organizational and/or process improvement initiatives.
  • 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
  • Ensuring 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
  • Collaborate crossfunctionally to identify areas for process improvement in clinical study execution and contribute to the optimization of these processes
  • 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 including Role-Based Curriculum
  • 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 crossstudy issues requiring resolution by the vendor and/or Amgen

Win

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications.


Basic Qualifications:


  • Doctorate degree & 6 years of clinical program experience OR
  • Master's degree & 10 years of clinical program experience OR
  • Bachelor's degre
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