Director Clinical Project Management

Clinical Development Operations Bothell, Washington Seattle, Washington


Description

Summary: 

Director, Clinical Project Management is responsible for the oversight of the Global Operational Leads across multiple early and late phase programs.  The Director ensures all programs are delivered on-time, on-budget, and with consistency and high quality.    In coordination with the department head and other director level roles, this position is also responsible for the development and maintenance of the functional area and company-wide process improvement.  Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.



Principal Responsibilities:

The duties and responsibilities include but are not limited to the following:

  • Manages the day to day operations of the Clinical Project Management group across multiple compounds
  • Ensure the program consistently project accurate enrollment, costs, and drug forecasts and meet program, department, and corporate goal deliverables
  • Execute clinical development strategy and vision, assess and communicate risk at program level in coordination with the Global Operations Lead and CPM Leadership Team (LT)
  • Oversight of program activities including deliverables to Sr. Mgmt
  • Point of escalation for GOL on alliance and vendor management in partner with Vendor Strategy Management group
  • Provide senior level operational review of protocols and other critical documents in the clinical trials.  Serve as operations representative for independent review of protocols at CPC
  • Manage and develop the GOLs, mentors CPM staff
  • Provide senior level participation at applicable internal and vendor meetings
  • Participates in, or leads process improvement initiatives for CPM group, including forecasting, budgeting, enrollment, and cross-functional deliverables, including developing and maintaining SOPs
  • Periodic risk assessments and review of mitigation plans across program(s)

 

Qualifications:

  • At least 12 years of pharmaceutical/biotech clinical development experience, including 8 years as a Clinical Project Manager (or equivalent)
  • 5 years supervisor experience preferred
  • Experience must include Phase I-III oncology trials, CRO and vendor management, significant experience managing international clinical trials, and project and contract management
  • Expertise with suite of MS Office applications
  • Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders.  Knows how to summarize, represent and communicate the key points for others to effectively and expeditiously make important business decisions
  • Ability to apply project management disciplines, including adherence to corporate financial plans and operating strategies and the ability to direct the actions of project team personnel as appropriate
  • Effective in working with global teams
  • Must be willing to travel up to 10%

 

Education:

  • BA/BS required, or at least 12 years pharmaceutical/biotech clinical development experience.  An advanced degree (Master’s or PhD) preferred
  • Project Management Professional (PMP) certification preferred

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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