Open PM positions at Seattle Genetics

For additional information or to apply for these positions, please visit their website at:

www.seattlegenetics.com/careers

or contact, Jessica Williams @ jwilliams@seagen.com

Associate Clinical Project Manager

A Clinical Project Manager Associate (CPMA) is responsible for assisting and/or leading a clinical trial or suite of clinical trials from protocol design to the final clinical study report.  May manage a sub-project for a given clinical trial or trials or may coordinate the efforts of an internal group or one or more vendors.

DETAILED DUTIES & RESPONSIBILITIES TYPICALLY INCLUDE:

The goal of a CPMA is to build project management skills by managing smaller projects or sub projects to ensure budgets, timelines and performance requirements are met.  CPMAs should gain confidence in resolving problems or conflicts by frequent interaction with outside customers and functional peer groups.  Specific duties are outlined below but are not limited to:
• Drives all aspects of small projects or sub-projects from initiation, planning, execution, control and closure.  Manages all aspects proactively.
• Creates or assists in creation of project budgets and assists to manage project costs to budgets.  Assists in development of enrollment projections, and drug supply needs as part of the budget.
• Responsible for creating and maintaining MS Project timelines for each assigned project.
• Assists with creation of Project Plans (e.g. Responsibility Table, and Communication Plans) for each project.
• May review and approve the site contract template and budget template and variations to the template.
• Becomes proficient at reviewing study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process).
• Compiles study metrics for performance and quality for management.
• Becomes proficient at negotiation and management of competing priorities across multiple functional areas.
• Prepares and manages RFP’s for vendors with oversight from manager.
• Prepares high-quality reports (financial, project, etc.) for CPM on program status and issues.
• Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.

REQUIREMENTS:

• BA/BS or equivalent is preferred with a minimum of 4 years of pharmaceutical or biotech research experience. 
• • Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred.
• • Highly effective organizational and communication skills. 
• • Ability to solve problems proactively. 
• • Willingness to travel approximately 10%. 
• • Proficiency with Excel and MS Project.

Clinical Project Manager/Sr. Clinical Project Manager

JOB SUMMARY:

A Clinical Project Manager (CPM) is responsible for the execution of a clinical trial or suite of clinical trials from protocol design to the final clinical study report.  They manage the process and people involved though matrix reporting.  The position is responsible for coordinating all efforts for the trial both within the Company and through a wide variety of vendors.  A CPM coordinates other functional groups that comprise the clinical department indication team for the product; specifically, statistics, clinical monitoring, data management, medical writing, medical and safety to insure proper conduct and timely completion of all projects.

DETAILED DUTIES & RESPONSIBILITIES TYPICALLY INCLUDE:

The goal of a CPM is to drive development projects utilizing best practices in order to ensure budgets, timelines and performance requirements are met.  Judgment is required to meet GCP, regulatory and SOPs and policies and to determine appropriate action.   The role requires active involvement, to meet schedules or resolve problems or conflicts, and entails frequent interaction with subordinates, outside customers, functional peer groups at various management levels and senior management.   Gaining project team cooperation, conducting presentations of technical information concerning specific projects and schedules and, solving technical problems, are keys to success.   Specific duties are outlined below but are not limited to:

• Manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s).

• Drives all aspects of the project management process from initiation, planning, execution, control and closure.  Manages all aspects proactively.

• Assists in developing protocol concept sheet (study design, entry criteria and schedule of activities table).  Reviews protocol and CRFs and tracks development to completion.

• Creates project budgets and manages cost to budgets.  Develops enrollment projection, and drug supply needs as part of the budget.

• Responsible for creating and maintaining MS Project timelines for each project, and uses these timelines to track and manage a project’s progress.

• Responsible for creating Project Plans (e.g. Responsibility Table, and Communication Plans) and Study Data Sheet for each project.

• Reviews and approves the site contract template and budget template.  Will review and approve any variations to the template.

• Reviews study-related support materials created by the Monitoring and Data Management Groups (e.g. study manual, monitoring plan, edit check manual, Listing Review process).

• Reviews actual trial conduct and quality at all levels (i.e. monitoring, data management).

• Responsible for periodic (weekly, or as needed) clinical trial team meetings.

• Reviews study metrics for performance and quality with the team and management.

• Ensures review of Clinical Trial Master File for completeness.

• Position has overall responsibility to deliver the projects on time and on budget.  The CPM drives study conduct to timely completion in compliance with all regulations and SOPs.

• Requires the ability to negotiate and manage competing priorities across multiple functional areas.

• Works with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects.  The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs.

• Insures all groups provide deliverables (i.e. query generation and resolution, data base lock, study report).  Informs all groups of deliverables and timeline, project developments and insures completion according to timelines.

• Manage and coordinate all vendors involved in the clinical trials, e.g. central lab, CROs, including managing the RFP processes and overall budget for each.

• Prepares high-quality reports (financial, project, etc.) for management on program status and issues.

• Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.

REQUIREMENTS:

• BA/BS or equivalent is preferred with a minimum of 6 years of pharmaceutical or biotech research experience

• Highly effective organizational and communication skills

• Knowledge of CFR and GCP/ICH requirements is required, as well as European Clinical Trial Directive knowledge is preferred.

• Demonstrated leadership skills and the ability to solve problems proactively

• Willingness to travel approximately 10%

• Proficiency with Excel, MS Project, Contract development and vendor oversight.  CRO management experience a plus.

• Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term objectives of the Company

• Project Management Certification (PMP) is a plus

Seattle Genetics is an Equal Opportunity Employer