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CDx Project Manager

Precision for Medicine

Precision for Medicine

Frederick, MD, USA
Posted on Wednesday, July 12, 2023

Position Summary:

The Project Manager, CDx and Commercial Project Management will be responsible for directing project management activities related to in vitro diagnostics (IVD)/ companion diagnostic product development programs. The position requires experience running complex projects within the product development environment, a natural aptitude for keeping track of multiple details, and strong planning and communication skills.

Essential functions of the job include but are not limited to:

Design Control Lead for CDx / Product Development:

  • Oversee delivery of laboratory services under design control at Precision’s ISO 13485:2016, ISO 15189:2012, CAP/CLIA certified facility
  • Design and develop logistical plans, making recommendations to clients on study designs, to ensure all aspects of design control are achieved
  • Design, implement, and manage new and existing projects under design control in a manner consistent with Precision For Medicine’s repository mission and management philosophy
  • Author or review design control documentation as appropriate such as design requirements, product requirements, manufacturing assessments, design and development plans, FMEAs, risk management plans, raw material documents, and part number documents
  • Establish and maintain the Device History File, and all elements therein
  • Serve as the laboratory design control lead for the development of companion diagnostics (CDx), spanning feasibility, development, design verification, and design validation through to regulatory clearance or approval
  • Provide support for activities related to CDx post-market requirements and commercial sample testing

Communications and Reporting:

  • Drive the projects by developing communication and reporting structures and processes for both internal and external clients and collaborators to keep projects on time and on budget
  • Assist internal and external clients and collaborators in the design and implementation of studies supporting the product development process through all phases of design control
  • Manage cross-functional internal and external project teams by driving meeting management, agendas, minutes, and all key project deliverables
  • Prepare reports and correspondences to internal and external clients, collaborators, and department director
  • Resolve and assist in resolution of operational issues

Project Management:

  • Take accountability for the project plan, designing efficient tools that meet the needs of the program and ensuring that all information is up to date and clear of obsolete documentation
  • Manage all tasks in an efficient manner
  • Engage with all repository operations through interacting, coordinating, and prioritizing activities
  • Coordinate with cross functional team leads on complex projects to ensure all deliverables are tracking to agreed timelines
  • Ensure quality control procedures are executed
  • Enforce applicable regulations and standards
  • Review and approve all documentation associated with project(s)
  • Create relevant metrics for business and project measurement
  • Ability to respond timely to emergency events
  • Perform other duties as assigned

Business Development:

  • Evaluate contract/project budgets on a monthly basis and report unexpected variances to department director
  • Participate in bidding on new projects, writing proposals, and preparing budgets
  • Coordinate the development and implementation of new laboratory projects


Minimum Required:

  • Bachelor’s Degree in Biology or related field
  • 3 years’ experience developing products under design control
  • 3 years’ experience in Project Management in a scientific or technical discipline managing/leading large/complex projects

Other Required:

  • Excellent communication, interpersonal, organizational and multi-tasking skills
  • Strong understanding of QSR and ISO regulatory requirements
  • Strong understanding and experience with Design Control requirements
  • Excellent use of judgment and discretion required
  • Proficiency in MS Office (Word, Excel, PowerPoint)
  • Highly organized and detail-oriented
  • Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities
  • Ability to read, write, speak fluently and comprehend the English language


  • S. or Ph.D. with minimum of 5 years’ experience developing products under design control
  • Minimum of 5 years’ experience in Project Management in a scientific or technical discipline managing/leading large/complex projects
  • Experience in developing in vitro diagnostic products under design control
  • Experience in writing technical grant or contract proposal responses
  • Experience with project management software such as MS Project

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$95,000$140,000 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC