CDx Program Lead - Regulated Med Tech

GForce Life Sciences

Lake Forest (IL)

On-site

USD 90,000 - 130,000

Full time

9 days ago

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Job summary

GForce Life Sciences is seeking an experienced Project Manager to lead multiple cross-functional projects supporting Companion Diagnostic (CDx) initiatives within a regulated medical device and biotechnology environment. You will guide projects from planning through execution, ensuring delivery on time, within scope and budget while maintaining compliance with industry standards.

Responsibilities include coordinating domestic and international stakeholders, tracking budgets and risks, and

Qualifications

Minimum 5 years of project management experience in medical device/biotechnology/pharmaceutical industry.
Experience managing multiple cross-functional projects in a regulated environment.
Knowledge of FDA regulations, GMP, and quality management systems.
Experience supporting Companion Diagnostic (CDx) programs is preferred.

Responsibilities

Lead multiple cross-functional projects through full lifecycle from planning to completion.
Define scope, charters, timelines, budgets, and resource plans.
Coordinate domestic and international stakeholders to meet milestones.
Monitor schedules, budgets, risks, and documentation; implement mitigations.
Prepare updates and reports for senior leadership; use Excel and Power BI.
Ensure compliance with medical device regulations and quality standards.
Foster a collaborative, accountable project team environment.