Associate Director Clinical Project Management
The Associate Director, Clinical Project Management is responsible for the oversight of the execution of all portfolio of clinical trials within a development program(s), including supervision of CPMs as applicable. The AD ensures that all clinical trials within the program(s) 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.
The duties and responsibilities include but are not limited to the following:
- 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
- Potential to serve as the Global Operations Lead (GOL) for program(s) and facilitate GDT meeting. This role serves as the primary operations escalation point for issues between the study teams and GDT. The GOL safeguards operational consistency across the portfolio studies. The GDOL 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
- 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
- Provide written and verbal summaries of study status and risks to senior management and optimize information distribution and communication to study teams (e.g., monthly reporting and dashboards)
- Coordinate program level data packages and necessary operations inputs to BOD, 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 10 years of pharmaceutical/biotech clinical development experience, including 6 years as a Clinical Project Manager (or equivalent)
- 2 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%
The above statements are intended to describe the general nature and level of work performed by people assigned to this job. They are not intended to be an exhaustive list of responsibilities, duties and requirements.
- BA/BS required, or at least 10 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.