Insmed Incorporated

Director, Project Management, Clinical Operations

ID
2020-1273
Job Function
Clinical Operations

Company Description

About Insmed!

 

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.  Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

Overview

About the Role!

  • This position reports directly to the Senior Director, Clinical Operations (EU).
  • This position does not have direct reports.
  • Will be based in Bridgewater, NJ.

The Director, Project Management / Clinical Operations is responsible for overseeing all clinical trials conducted within Insmed with regard to study metrics, Key Performance Indicators (KPIs), timelines and budgets and will be working closely with the Insmed Program leads, the Insmed Project Management Department, as well as with the individual Insmed Clinical Trial Managers (US & Europe).  In addition, the Project Manager will also have oversight and accountability for the departmental budget and will function as the primary liaison with the preferred provider partner CRO to ensure all timelines and budget parameters are met.

Responsibilities

Representative responsibilities will include, but not necessarily be limited to, the following: 

  • Maintains global integrated Clinical Operation project plans, project timelines, risk management, plans and communication plans. Supports scenario planning and critical path analyses. Identifies problems and works with team to resolve. Leverages their network to influence across the organization.
  • Develops and supports content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget. 
  • Serves as the primary liaison at the CRO Partnership level between Insmed & the partner CRO to ensure metrics, dashboards, KPIs, timelines, budget status are always up to date / actual throughout the study conduct.
  • Manages vendors’ adherence to contractual obligations at the Partnership level.  
  • Coordinate with various team members and assist to select appropriate vendor.
  • Supports trial managers in monitoring study metrics to ensure quality and performance standards are met by vendors and assigned project staff during the course of all trials.
  • Provides regular study status updates to senior management in close collaboration with the Insmed program leads and Clinical Trial Managers (US & Europe). Ensures consistency and standardization across all reporting tools.
  • Can support the logistics of various team meetings including developing agendas and documenting decisions and action items. Follows through on assignments and ensures team members deliver on action items. Identifies organizational gaps and influences the project environment to address gaps that impact the program/project.
  • Support the Trial Managers/Program Directors in budget and timeline modeling/forecasting scenarios to assist study design and presentations to executive management. Ensure compliance to all reporting standards and timeframes.
  • Responsible for the comprehensive maintenance and oversight of departmental budget and variance management.  In conjunction with Program Directors/Study Managers and Finance, ensures the collection of all relevant data and incorporation into the budget tool.  Works with Finance to secure adequate budget/resourcing and tracks team performance against the budget.  Ensures consistent reporting of budget across programs.
  • Contribute to wider organizational goals and/or activities as assigned.  
  •  

Qualifications

About you!

 

Qualifications:

  • Requires a bachelor’s degree in the life sciences, healthcare or related field
  • A minimum of 10 years of clinical trial management experience within the pharmaceutical/biotechnology industry managing the logistics of clinical trial execution

Knowledge & Experience:

  • Experience managing large and/or complex studies and having a proven track record in being able to keep oversight / track on metrics, KPIs, budget & timelines in an international Clinical Operations team setting
  • PMP Certification
  • High level proficiency in MS project
  • Excellent team player
  • Outstanding written and oral communication skills, as well as conflict management, time management and organizational skills
  • Demonstrated high level computer skills (MS Office, PowerPoint)
  • Fluency in English

Additional Information

We offer a competitive benefits package that includes healthdentalvisionwellness programs, employee discount programs, 401k and more. This position is also bonus eligible.

 

Insmed is an Equal Opportunity Employer and will evaluate all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Please note that we review every submission and we will keep all submissions on file for six months.

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