Project Manager, Clinical Operations (Contract) | BioNJ Talent Services

Project Manager, Clinical Operations (Contract)

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

Development and realization of plans associated with executing strategic projects and designated priorities for orphan drug disease programs. This position leads cross-functional teams and work streams, coordinating interactions and ensuring timely and optimal execution of clinical programs and regulatory submissions. This position is responsible for identifying and resolving issues as well as tracking and communicating progress and results.

This position requires experience in applying project management tools such as Microsoft Project or Excel. A general understanding of worldwide regulatory requirements, and clinical trial expertise from all phases of drug development. Experience in clinical development programs (Phase I-IV) and global regulatory submissions is required. This position involves participation on project teams and interactions with Clinical Research, Data Management, Medical Writing and Regulatory Affairs staffs to coordinate the activities associated with drug development projects and goals.

Roles and Responsibilities
Develop integrated plans for executing strategic projects as defined by the Clinical Operations Management Team and other priority projects as needed to deliver on goals. Scope includes, but is not limited to projects involving clinical development programs and regulatory submissions.
Ensure detailed plans and timing to meet strategic intent and achieve critical milestones.
Consolidate, Collate and report data from multiple sources, and update and maintain various tracking reports and Dash Boards
Collaborate with and guide Clinical Operations and Research staff on project prioritization and resource assessment and allocation. Focus on optimizing value, priorities, time, resources and risks
Lead conflict resolution at project team level and facilitate decision-making within the team. Escalate when decision rights exceed established boundaries.
Monitor progress of project plans. Ensure adherence to plan and strategy; maintain and manipulate detailed project plans using generally accepted project management tools such as Microsoft Project or Excel.
Regularly apprise key stakeholders on the project status
Provide process and tools to facilitate planning, reporting and governance
Ensure compliance to all applicable procedures and regulatory requirements
Identify and implement best practices to drive simplification, standardization and productivity
Foster high performance team work and maintain strong working relationships with operational and functional leadership
Foster high performance team work and maintain strong working relationships with clinical operational and cross functional teams.

Qualifications: 

Requirements
BS or BA in Natural Science, Pharmacy, Biology or a related pharmaceutical science. Project Management courses and certification are desirable.
Minimum of 5 years experience in one or more areas of clinical operations, clinical research or regulatory affairs. Understanding GCP is essential
Demonstrated experience in project management of complex projects involving cross functional, multi-site, international teams. Well organized and capable of managing multiple projects with respect to priorities
Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership.
Demonstrated ability to drive work and get results as well as take risks and drive decisions.
Demonstrated ability to connect and collaborate across functions to enable. development and execution of realistic plans.
Experience in planning and facilitation of meetings.
Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management.
Demonstrated command of project management tools i.e. Microsoft Project & Microsoft Excel and other Project Management tools
Demonstrated ability to consolidate, collate, and report data from multiple sources, including dash boarding using generally accepted Project Management tools.

Travel
0-5%

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Project Management