The Director, Global Clinical Project Manager is responsible for the oversight of the execution of a portfolio of clinical trials within select late stage development program(s), determined based on the greater complexity and impact of the program. The GCPM partners with the Global Development Lead to drive development strategy and ensures that all clinical trials within the program(s) are delivered on-time, on-budget, and with consistency and high quality. The Director, GCPM exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. 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.
The duties and responsibilities include but are not limited to the following:
- Partners with Global Development Lead to drive development of the clinical development strategy for a product
- Manage operations of the Global Development Team, working in close partnership with the Global Development Lead and Development functional leaders
- Partners with Program and Portfolio Management to coordinate the clinical development strategy and clinical deliverables within the broader product strategy
- Partners with other GCPMs to manage responsibilities below and delegates to GCPM, as appropriate
- Execute clinical development strategy and vision, assess and communicate risk at program level in coordination with the Global Development Team. Lead operational strategy to meet program, department, and corporate goal deliverables
- Primary point person to facilitate and optimize communications between the study teams and senior management (e.g., periodic review of study status and risks, monthly reporting, etc.).
- Maintain high-quality program-wide clinical development project plans that align with overall development strategy and drive communication, scenario planning and decision-making
- Serve as the primary operations escalation point for issues between the study teams and GDT. The GOL safeguards operational consistency across the portfolio of studies. The GOL is responsible for oversight of delivery on Clinical Operations activities for the program from feasibility to submission
- Manage and develop the Clinical Project Managers (CPM) assigned to studies within the program, mentors CPM staff
- Provide early CPM support (i.e., resource needs, feasibility, protocol writing, etc.) for a study concept until a study CPM is formally assigned to a clinical trial
- Coordinate program level data packages and necessary operations inputs to BOD, Program Strategy Review, etc.
- Provide content for governance meetings on study budgets, timelines, and operational feasibility and serve as Operations SME, if applicable
- Clinical operations counterpart in partner alliance programs
- 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
- Provide senior level participation at applicable study level, internal or 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
- Partner with Vendor Strategy Management group on establishing processes for vendor selection, management, escalation, and oversight
- Periodic risk assessments and review of mitigation plans across protocols and program(s)
- At least 12 years of pharmaceutical/biotech clinical development experience, including 6-8 years as a Clinical Project Manager (or equivalent)
- 3 years supervisor experience required, 5 years 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%
- BA/BS required.
- 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, Seagen 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 Seagen, please visit www.seagen.com.
Seagen 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.