Executive Director Clinical Program Operations - General Medicine

Amgen Inc.

3.6

(9)

Multiple Locations (Remote)

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-185837

    Position summary

    al 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.

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging